CELLEX CELLEXUSARecalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 10705030100009), received between Aug 13, 2015 and Apr 30, 2026 — classified as 4 deaths, 59 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (51 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM #10: BUFFY VOLUME EXCEEDED WAS RECEIVED DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THERE WERE NO ISSUES OBSERVED DURING THE TREATMENT. THE CUSTOMER REPORTED THE TREATMENT WAS COMPLETED, HOWEVER, AN UNPLANNED BLOOD TRANSFUSION WAS ADMINSTERED TO THE PATIENT AFTER TREATMENT. ALTHOUGH REQUESTED, NO REASONING BEHIND THE TRANSFUSION HAS BEEN PROVIDED. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE AND IN GOOD CONDITIONS BEFORE THE TRANSFUSION. NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 25046259 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CONTACTED THERAKOS TO REPORT A PATIENT EXPERIENCING HYPOTENSION DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER CALLED THERAKOS PRODUCT SUPPORT (PS) DURING A DNM PROCEDURE TO REPORT ALARM #45: RED BLOOD CELL PUMP ALARM WITH 388 ML OF WHOLE BLOOD PROCESSED, HEMATOCRIT (HCT) 28.9%, PLATELETS (PLT) 19,000, ACDA 12:1, DARK PLASMA, COLLECT/RETURN RATE 25/30ML/MIN. THE NURSE STATED THE INTERFACE WAS LOW BUT HAD FOLLOWED CORRECTIVE ACTIONS FOR AN ELEVATED INTERFACE. THE TREATMENT WAS PAUSED WITH THE BOWL OPTIC SENSOR READING (BOS) OF 114. AFTER STOPPING, CLEANING THE BOWL OPTIC LENS, AND RESTARTING AT A RATE OF 15/20 ML/MIN, THE ALARM POSTED WITH BOS OF 110. PS ASKED THE NURSE TO CHECK THE KIT FOR KINKS OR OBSTRUCTIONS, AND THE NURSE NOTED THE RED CELLS ARE IN THE BOTTOM OF THE BOWL. PS EXPLAINED THAT THE DARK PLASMA LIKELY INTERFERED WITH THE BOS AND TO ADJUST THE BOWL OPTIC THRESHOLD (BOT) LOWER TO RAISE THE RED CELL LAYER TO THE CORRECT LEVEL. THE BOT WAS ADJUSTED SLOWLY DOWN TO 90 WITH A BOS OF 110. THE NURSE MENTIONED THE PATIENT'S BLOOD PRESSURE (BP) WAS DROPPING TO 90/35 FROM THE BASELINE OF 110/45. THE CUSTOMER PAUSED THE PROCEDURE AND NOTIFIED TH

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25019481 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CONTACTED THERAKOS TO REPORT A PATIENT FEELING "UNWELL" DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. HEMOGLOBIN HAD DROPPED TO 6.9, SO A BLOOD TRANSFUSION WAS ADMINISTERED. THE TREATMENT HAD BEGUN WITH HEMATOCRIT AT 22%. AT THE START OF ECP TREATMENT, SYSTOLIC BLOOD PRESSURE WAS 140MMHG, BUT DROPPED TO 90MMHG DURING TREATMENT. SPO2 WAS ALSO UNSTABLE, RANGING FROM AROUND 90 TO 97%, SO A SMALL AMOUNT OF OXYGEN WAS ADMINISTERED VIA THE NASAL PASSAGE. THE WHOLE BLOOD PROCESSING VOLUME WAS CHANGED TO 1250ML, AND TREATMENT CONTINUED, AFTER WHICH IT WAS TERMINATED. THE CUSTOMER HAS STATED THAT THEY BELIEVE THE PATIENT'S UNDERLYING CONDITION COULD HAVE CAUSED OR CONTRIBUTED TO THE INTERVENTIONS PERFORMED, HOWEVER, IT IS UNKNOWN IF THE ECP TREATMENT NECESSITATED THE OXYGEN DELIVERY. THE PATIENT REMAINS HOSPITALIZED. IT IS UNKNOWN IF THE PATIENT WILL BE CONTINUING ECP TREATMENT. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

  Patient problems: Anemia; High Blood Pressure/ Hypertension; Hypoxia; Low Oxygen Saturation; Malaise; Tachycardia

  MAUDE report 24735514 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED DYSPNEA, OXYGEN DESATURATION, TACHYPNEA, TACHYCARDIA, AND HYPERTENSION FOLLOWING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT WAS UNDERGOING ECP THERAPY FOR THE TREATMENT OF CHRONIC MULTIPLE SYSTEM GVHD OF THE JOINTS, MOUTH AND LIVER. THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT THEIR FIRST ECP TREATMENT PROCEDURE ON (B)(6) 2024. THE CUSTOMER STATED THAT THE PATIENT WAS ALSO BEING TREATED FOR PRE-EXISTING HYPERTENSION AND THE PATIENT WAS GIVEN AN ANTI-HYPERTENSIVE, AMLODIPINE 2.5 MG, AT HOME PRIOR TO THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW HOW FAR IN ADVANCE OF THE PATIENT'S ECP TREATMENT PROCEDURE THE ANTI-HYPERTENSIVE WAS GIVEN TO THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT'S PRETREATMENT VITAL SIGNS WERE BLOOD PRESSURE 130/98, RESPIRATORY RATE 24, HEART RATE126, AND TEMPERATURE 36.6. THE CUSTOMER REPORTED THAT 1500MLS OF WHOLE BLOOD WAS PROCESSED IN DOUBLE NEEDLE MODE WITH A COLLECT RATE OF 30ML/MIN AND A RETURN RATE OF 35ML/MIN DURING THE PATIENT'S ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT'S ECP TREATMENT P

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dyspnea; High Blood Pressure/ Hypertension; Low Oxygen Saturation; Tachycardia

  MAUDE report 20789064 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DISTRIBUTOR REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED ANEMIA FOLLOWING THEIR ECP TREATMENT PROCEDURES. THE DISTRIBUTOR STATED THAT THE PATIENT WAS MENTIONED WITHIN A SLIDE PRESENTATION ENTITLED "ECP THERAPY FOR CHRONIC GVHD - NEW DEVELOPMENTS WITH CELLULAR THERAPY AND NOVEL AGENTS" WHICH WAS PRESENTED AT THE ANNUAL MEETING OF THE JAPANESE SOCIETY FOR HISTOCOMPATIBILITY AND IMMUNOGENETICS HELD ON SEPTEMBER 27, 2024. THE SLIDE PRESENTATION REPORTED THAT THE PATIENT WAS BEING TREATED WITH ECP FOR CHRONIC MUSCULAR GRAFT VERSUS HOST DISEASE (GVHD). THE PRESENTATION STATED THAT THE PATIENT HAD BECOME PREDNISOLONE (12.5MG) AND MYCOPHENOLATE MOFETIL (1,000MG) DEPENDENT AND WAS INTOLERANT TO IBRUTINIB SO ECP WAS INTRODUCED. THE PRESENTATION REPORTED THAT THE PATIENT WAS ALREADY EXPERIENCING MILD ANEMIA, 10.7G/DL, PRIOR TO STARTING THEIR ECP THERAPY. THE PRESENTATION STATED THAT THE PATIENT BEGAN THEIR ECP TREATMENTS ON (B)(6) 2023. THE PRESENTATION REPORTED THAT THE PATIENT'S ECP TREATMENT FREQUENCY WAS ONCE A DAY FOR THREE CONSECUTIVE DAYS FOR THE FIRST WEEK FOLLOWED BY ONCE A DAY FOR TWO CONSECUTIVE DAYS WEEKLY FOR WEEKS 2-9. THE PRESENTATION STATED THAT

  Patient problems: Anemia

  MAUDE report 20584916 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED PARESTHESIA, HYPOCALCEMIA, AND HYPOTENSION DURING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT ACDA AT A RATIO OF 8:1 WAS THE ANTICOAGULANT THAT WAS USED DURING THE PATIENT'S ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT WAS ALSO RECEIVING A CALCIUM DRIP, 0.5 GM/HR, DELIVERED VIA THE CELLEX INSTRUMENT'S RETURN LINE DURING THE PATIENT'S ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT CALCIUM IS NORMALLY DELIVERED VIA THE CELLEX INSTRUMENT'S RETURN LINE DURING ECP TREATMENT PROCEDURES THAT USE ACDA AS THE ANTICOAGULANT. THE CUSTOMER REPORTED THAT AT 100MLS OF WHOLE BLOOD PROCESSED (WBP) THE PATIENT BEGAN TO COMPLAIN OF PARESTHESIA. THE CUSTOMER STATED THAT THEY THEN PAUSED THE PATIENT'S ECP TREATMENT PROCEDURE AND ORAL TUMS WAS GIVEN TO THE PATIENT. THE CUSTOMER REPORTED THAT THEY ALSO INCREASED THE PATIENT'S CALCIUM DRIP FROM 0.5 GM/HR TO 1.0 GM/HR. IN ADDITION, THE CUSTOMER STATED THAT A SERUM IONIZED CALCIUM LEVEL WAS DRAWN, WHICH INDICATED THE PATIENT'S BLOOD CALCIUM LEVEL WAS 1.05MG/DL. THE CUSTOMER REPORTED THAT THEY THEN CHANGED THE ECP TREATMENT PROCEDURE'S ACDA

  Patient problems: Hypocalcemia; Low Blood Pressure/ Hypotension; Paresthesia

  MAUDE report 20403275 ↗
• InjuryJul 3, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED MALAISE, SHAKING HANDS, PARESTHESIA AND HYPOCALCEMIA DURING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED LESS THAN 300ML OF WHOLE BLOOD HAD BEEN PROCESSED AT THE TIME OF THE EVENT. THE CUSTOMER REPORTED THAT DUE TO THE PATIENT'S HYPOCALCEMIA 1000MG OF ORAL CALCIUM WAS ADMINISTERED TO THE PATIENT. THE CUSTOMER REPORTED HYPOCALCEMIA WAS CONFIRMED WITH A BLOOD SAMPLE AND THE ORAL CALCIUM WAS FOLLOWED BY A CALCIUM INJECTION CONSISTING OF 4MLS OF CALCIUM GLUCONATE (CALCIUM GLUCONATE B BRAUN 94 MG/ML). THE CUSTOMER STATED THE PATIENT RECOVERED AFTER THE INJECTION AND THE ECP TREATMENT CONTINUED. THE CUSTOMER REPORTED MULTIPLE ALARM #17: RETURN PRESSURE ALARMS OCCURRED, AND BLOOD CLOTTING WAS OBSERVED IN THE RETURN LINE. THE CUSTOMER STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS PERFORMED WITH ACD-A AS THE ANTICOAGULANT AT A RATIO OF 1:12. THE CUSTOMER REPORTED THEY NOTICED THAT THE ACD-A AND SALINE BAGS HAD BEEN INCORRECTLY ATTACHED DURING SETUP OF THE ECP TREATMENT. THE CUSTOMER ABORTED THE ECP TREATMENT AND DID NOT RETURN RESIDUAL BLOOD WITHIN THE KIT TO THE PATIENT. THE CUSTOMER STATED

  Patient problems: Hypocalcemia; Malaise; Paresthesia; Shaking/Tremors

  MAUDE report 19669445 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DISTRIBUTOR REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED NUMBNESS AND HYPOCALCEMIA BOTH DURING AND AFTER THEIR ECP TREATMENT PROCEDURE. THE DISTRIBUTOR STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE ON (B)(6) 2024 WAS PERFORMED WITH ACDA AS THE ANTICOAGULANT AT A RATIO OF 12:1 AND A FLOW RATE OF 1.0 ML/MIN/TOTAL BLOOD VOLUME. THE DISTRIBUTOR REPORTED THAT THE PATIENT COMPLAINED OF NUMBNESS IN THEIR LIMBS DURING THEIR ECP TREATMENT PROCEDURE. THE DISTRIBUTOR STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BOTH TREATED CELLS AND BLOOD RETURNED TO THE PATIENT. THE DISTRIBUTOR REPORTED THAT THE PATIENT CONTINUED TO COMPLAIN OF NUMBNESS IN THEIR LIMBS EVEN AFTER THEIR COMPLETED ECP TREATMENT PROCEDURE. THE DISTRIBUTOR STATED THAT SINCE THE PATIENT HAS ALWAYS HAD LOW BLOOD CALCIUM LEVELS, 0.8 MMOL/L, DUE TO THEIR UNDERLYING CONDITION, THE PATIENT'S MEDICAL STAFF DECIDED TO MEASURE THE PATIENT'S BLOOD CALCIUM LEVEL AFTER THEIR COMPLETED ECP TREATMENT PROCEDURE. THE DISTRIBUTOR STATED THAT THE PATIENT'S CALCIUM LEVEL BEFORE THEIR ECP TREATMENT PROCEDURE WAS 0.8 MMOL/L AND THEIR CALCIUM LEVEL AFTER THEIR ECP TREATMENT PROCE

  Patient problems: Hypocalcemia; Numbness

  MAUDE report 19564289 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A PATIENT WHO WAS UNDERGOING THEIR VERY FIRST EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT PROCEDURE FOR BILATERAL LUNG TRANSPLANT REJECTION EXPERIENCED OXYGEN DESATURATION AND A PULMONARY EMBOLISM FOLLOWING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE ON (B)(6) 2024 AT 8:30 AM WAS SUCCESSFULLY COMPLETED WITHOUT ANY ISSUES OR ALARMS. THE CUSTOMER REPORTED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS COMPLETED USING THE PATIENT'S TWO-WAY TENNELED CENTRAL VENOUS CATHETER WHICH WAS IMPLANTED ON (B)(6) 2024 AND ACDA AT A RATIO OF 10:1 WAS USED AS THE ANTICOAGULANT. THE CUSTOMER STATED THAT THE PATIENT EXPERIENCED OXYGEN DESATURATION (OXYGEN SATURATION 88% ON ROOM AIR) AFTER RETURNING HOME, WHICH REQUIRED THEM TO INCREASE THE PATIENT'S OXYGEN THERAPY REQUIREMENT. THE CUSTOMER REPORTED THAT ON (B)(6) 2024 THE PATIENT WAS HOSPITALIZED FOR A SUSPECTED LUNG INFECTION. HOWEVER, A LUNG INFECTION WAS RULED OUT AS THE PATIENT'S INFLAMMATORY MARKERS AND CULTURES WERE NEGATIVE. THE CUSTOMER STATED THAT THE PATIENT UNDERWENT AN ANGIO-CT SCAN ON (B)(6) 2024 WHICH REVEALED SMALL ENDOLUMINAL FILLING DEFECTS WITH THROMBOEMBO

  Patient problems: Low Oxygen Saturation; Pulmonary Embolism

  MAUDE report 19226325 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A PEDIATRIC EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED DYSPNEA FOLLOWING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT WAS BEING TREATED WITH ECP FOR ACUTE GRAFT VERSUS HOST DISEASE. THE CUSTOMER STATED THAT THE PATIENT WAS AN INPATIENT AND UNWELL DUE TO THEIR UNDERLYING CONDITION. THE CUSTOMER REPORTED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS PERFORMED IN SINGLE NEEDLE MODE DUE TO VENOUS ACCESS ISSUES. THE CUSTOMER STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS SUCCESSFULLY COMPLETED. HOWEVER, THE CUSTOMER REPORTED THAT THE PATIENT WAS "SLIGHTLY" OVER THEIR 15% SAFE EXTRACORPOREAL BLOOD VOLUME (ECV) BY 2MLS. THE CUSTOMER STATED THAT DURING THE PATIENT'S ECP TREATMENT PROCEDURE 762MLS OF WHOLE BLOOD WAS PROCESSED AND THE PATIENT HAD AN END FLUID BALANCE OF 310MLS. THE CUSTOMER REPORTED THAT THE PATIENT WAS STABLE THROUGHOUT THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT OVERNIGHT, SEVERAL HOURS POST THE PATIENT'S ECP TREATMENT PROCEDURE, THE PATIENT COMPLAINED OF DYSPNEA. THE CUSTOMER REPORTED THAT THE PATIENT'S OXYGEN SATURATION WAS SATISFACTORY. THE CUSTOMER STATED THAT THE PATIENT WAS GIVEN THE

  Patient problems: Dyspnea

  MAUDE report 18603558 ↗
• InjuryDec 14, 2023Insufficient Device Problem Information; Air/Gas in Device; Insufficient Device Problem Information; Air/Gas in Device

  THE DISTRIBUTOR REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED CHEST PAIN, DYSPNEA, BLURRED VISION, HEADACHE, NAUSEA, PARESTHESIA, AND A POSSIBLE AIR EMBOLISM DURING THEIR ECP TREATMENT PROCEDURE. THE DISTRIBUTOR REPORTED THAT SEVERAL ALARM #53: RETURN LINE AIR DETECTED ALARMS OCCURRED DURING THE PATIENT'S ECP TREATMENT PROCEDURE, BUT THEY WERE ABLE TO CONTINUE WITH THE PATIENT'S ECP TREATMENT PROCEDURE. THE DISTRIBUTOR STATED THAT NEAR THE END OF THE PATIENT'S ECP TREATMENT PROCEDURE WHEN THE CELLEX INSTRUMENT WAS RETURNING THE LAST OF THE RETURN BAG CONTENTS TO THE PATIENT, THE PATIENT CLAIMED THAT SHE DETECTED AIR IN THE INSTRUMENT'S RETURN LINE. THE DISTRIBUTOR REPORTED THAT THE PATIENT THEN "MANUALLY CLOSED THEIR IV" AS THEY BEGAN TO EXPERIENCE DYSPNEA. THE DISTRIBUTOR STATED THAT THE PATIENT CONTACTED A NURSE'S AIDE WHO THEN STOPPED THE PATIENT'S ECP TREATMENT PROCEDURE. THE DISTRIBUTOR REPORTED THAT THE PATIENT THEN BEGAN TO EXPERIENCE CHEST PAIN, DYSPNEA, BLURRED VISION, HEADACHE, NAUSEA, AND TINGLING IN BOTH THEIR FEET AND HANDS. THE DISTRIBUTOR STATED THAT THE ON-CALL PHYSICIAN WAS NOTIFIED, AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM DUE TO A

  Patient problems: Air Embolism; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Chest Pain; Dyspnea; Headache; Nausea; Paresthesia

  MAUDE report 18330293 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED DYSPNEA AND A PULMONARY EMBOLISM FOLLOWING THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT ON (B)(6) 2023 A GRAFT VERSUS HOST DISEASE (GVHD) PATIENT PRESENTED TO THEIR ECP UNIT COMPLAINING OF SHORTNESS OF BREATH. THE CUSTOMER REPORTED THAT THE PATIENT DID NOT RECEIVE THEIR SCHEDULED ECP TREATMENT PROCEDURE THAT DAY. THE CUSTOMER STATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL THAT DAY AND A CT SCAN CONFIRMED A BILATERAL PULMONARY EMBOLISM. THE CUSTOMER REPORTED THAT THE PATIENT'S LAST ECP TREATMENT PROCEDURE PRIOR TO THEIR PULMONARY EMBOLISM DIAGNOSIS WAS ON (B)(6) 2022 AND THIS TREATMENT WAS SUCCESSFULLY COMPLETED. THE CUSTOMER STATED THAT THE PATIENT HAD RECEIVED THREE ECP TREATMENT PROCEDURES AT THEIR FACILITY WITH A FREQUENCY OF EVERY TWO WEEKS. THE CUSTOMER REPORTED THAT THE ANTICOAGULANT HEPARIN WAS USED AT A RATIO OF 10:1 DURING THE PATIENT'S ECP TREATMENT PROCEDURES. THE CUSTOMER STATED THAT THE PATIENT DID NOT HAVE A HISTORY OF ELEVATED PLATELETS OR A CLOTTING DISORDER. THE CUSTOMER REPORTED THAT THE PATIENT WAS PRESCRIBED A HEPARIN PROTOCOL WHILE IN THE HOSPITAL FOR THEIR PUL

  Patient problems: Dyspnea; Pulmonary Embolism

  MAUDE report 16572585 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED CHEST PAIN, HEMATURIA, AND HEMOLYSIS DURING AN ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT WAS BEING TREATED FOR KIDNEY TRANSPLANT REJECTION. THE CUSTOMER REPORTED THAT AN ALARM #17: RETURN PRESSURE ALARM OCCURRED AT 1178ML OF WHOLE BLOOD PROCESSED. THE CUSTOMER STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS IN DOUBLE NEEDLE MODE. THE CUSTOMER REPORTED THAT THE INSTRUMENT'S DISPLAY STATED THAT THE INSTRUMENT'S RETURN PRESSURE WAS ABOVE THE MAXIMUM LIMIT AND THE CUSTOMER STATED THAT IT WAS IMPOSSIBLE TO RESET THIS ALARM. THE CUSTOMER STATED THAT THEY REMOVED THE CELLEX KIT'S RETURN LINE FROM THE PATIENT'S ACCESS AND DISCOVERED A CLOT AT THE PATIENT'S ACCESS. THE CUSTOMER REPORTED THAT A SALINE BOLUS WAS PERFORMED, AND A COUPLE OF CLOTS CAME OUT FROM THE RETURN LINE. THE CUSTOMER THEN ADMITTED THAT THEY HAD FORGOTTEN TO ADD HEPARIN INTO THE SALINE BAG DURING THE INSTALLATION OF THE CELLEX KIT THUS THE KIT HAD BEEN PRIMED ONLY WITH SALINE. THE CUSTOMER REPORTED THAT THEY HAD ADDED THE HEPARIN (12500U/500ML OF SALINE) AT THE END OF THE KIT PRIME AND BEFORE THE PATIENT HAD BEEN

  Patient problems: Chest Pain; Hematuria; Hemolysis

  MAUDE report 15499286 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED PARESTHESIA, DYSPNEA, NAUSEA, HEMOLYSIS, HEMATURIA, AND PNEUMONIA DURING AN ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THIS PARTICULAR PATIENT WAS NOT A NEW PATIENT AND HAS UNDERGONE MORE THAN 200 ECP TREATMENT PROCEDURES TO DATE. THE CUSTOMER REPORTED THAT THE PATIENT WAS A LITTLE GRUMPY PRIOR TO THEIR ECP TREATMENT PROCEDURE, BUT THIS WAS NOT UNUSUAL. THE CUSTOMER STATED THAT THE PATIENT DID NOT SEEM 100% NORMAL PRIOR TO THEIR ECP TREATMENT PROCEDURE BUT SEEMED "FINE" THE CUSTOMER REPORTED THAT THEY BEGAN THE PATIENT'S ECP TREATMENT PROCEDURE WITH ACDA AS THE ANTICOAGULANT. THE CUSTOMER STATED THAT THERE WAS AN ALARM #45: RED BLOOD CELL PUMP ALARM DURING THE PATIENT'S ECP TREATMENT PROCEDURE WHICH THEY WERE ABLE TO RESOLVE AND CONTINUE WITH THE TREATMENT. THE CUSTOMER REPORTED THAT THE PATIENT'S ECP TREATMENT PROCEDURE EVENTUALLY MOVED INTO THE PHOTOACTIVATION PHASE. THE CUSTOMER REPORTED THAT THE PHOTOACTIVATION TIME FOR THE TREATED CELLS WAS 43 MINUTES AND THAT THE CELLS SEEMED DARKER THAN USUAL. THE CUSTOMER REPORTED THAT MID-WAY THROUGH THE PATIENT'S ECP TREATMENT PROCEDURE THE PATIENT

  Patient problems: Dyspnea; Hematuria; Hemolysis; Nausea; Paresthesia; Pneumonia

  MAUDE report 13596240 ↗
• DeathDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DISTRIBUTOR REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED DYSPNEA, OXYGEN DESATURATION, PULMONARY EDEMA, TACHYCARDIA, SHOCK, MULTIPLE ORGAN FAILURE, HEMOPHAGOCYTIC SYNDROME, AND DEATH FOLLOWING AN ECP TREATMENT PROCEDURE ON (B)(6) 2021. THE DISTRIBUTOR STATED THAT THE PATIENT HAD BEEN USING OXYGEN PRIOR TO STARTING THEIR ECP TREATMENT PROCEDURE. THE DISTRIBUTOR REPORTED THAT THE PATIENT HAD COMPLAINED OF SHORTNESS OF BREATH THE DAY BEFORE HIS ECP TREATMENT PROCEDURE WHEN HE WAS ADMITTED FOR IMPLANTATION OF HIS CATHETER. THE DISTRIBUTOR STATED THAT AT THIS TIME IT WAS IDENTIFIED THAT THE PATIENT'S OXYGEN SATURATION WAS LESS THAN 90%, THUS THE PATIENT WAS PROVIDED WITH 2L/MIN OF OXYGEN DAILY. THE DISTRIBUTOR REPORTED THAT SINCE THEN, THE PATIENT HAD NOT BEEN WITHOUT THE OXYGEN. THE DISTRIBUTOR STATED THAT THE PATIENT WAS BEING TREATED WITH ECP FOR LUNG, EYE, AND LIVER GRAFT VERSUS HOST DISEASE (GVHD). THE DISTRIBUTOR REPORTED THAT THERE HAD BEEN NO ALARMS DURING THE PATIENT'S ECP TREATMENT PROCEDURE. HOWEVER, THE DISTRIBUTOR STATED THAT UPON REINFUSION OF THE TREATED CELLS, THE PATIENT BEGAN TO EXPERIENCE DYSPNEA, BASAL CRACKLES, AND OXYGEN DESATURATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dyspnea; Low Oxygen Saturation; Multiple Organ Dysfunction Syndrome; Pulmonary Edema; Shock; Tachycardia

  MAUDE report 13026517 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED A HEART ATTACK, SEIZURE, DYSPNEA, CONFUSION, HYPOTENSION, LOW HEMOGLOBIN, OXYGEN DESATURATION, SHOCK, TACHYCARDIA, AND INFECTION FOLLOWING AN ECP TREATMENT PROCEDURE ON (B)(6) 2021. THE CUSTOMER STATED THAT WITHIN TEN MINUTES OF COMPLETING THEIR ECP TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A TONIC-CLONIC SEIZURE. THE CUSTOMER REPORTED THAT AFTER THE SEIZURE THE PATIENT WAS IN SHOCK AND APPEARED CONFUSED. THE CUSTOMER STATED THAT THE PATIENT ALSO EXPERIENCED DYSPNEA WITH MINIMAL EXERTION FOLLOWING THEIR SEIZURE. IN ADDITION, THE CUSTOMER STATED THAT THE PATIENT'S BLOOD PRESSURE WAS INAUDIBLE FOLLOWING THEIR SEIZURE REQUIRING NOREPINEPHRINE TO BE ADMINISTERED TO THE PATIENT. THE CUSTOMER REPORTED THAT TACHYCARDIA WAS NOTED ON THE TRANSPORT MONITOR WHEN THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM (ER); HOWEVER, WHEN THE PATIENT ARRIVED AT THE ER AN ELECTROCARDIOGRAM WAS PERFORMED WHICH SHOWED THAT THE PATIENT WAS IN SINUS RHYTHM WITH EXTENSIVE ST SEGMENT ELEVATION. IN ADDITION, THE CUSTOMER STATED THAT THE PATIENT UNDERWENT A TRANS-THORACIC COLOR DOPPLER ECHOCARDIOGRAM AND THE PATIENT WAS RE

  Patient problems: Anemia; Bacterial Infection; Confusion/ Disorientation; Convulsion/Seizure; Dyspnea; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Myocardial Infarction; Septic Shock; Tachycardia

  MAUDE report 12097217 ↗
• InjuryMay 26, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED BOTH TACHYCARDIA AND HYPOTENSION DURING AN ECP TREATMENT PROCEDURE ON (B)(6) 2021. THE CUSTOMER STATED THAT AN ALARM #19: FLUID BALANCE LIMIT ALARM OCCURRED DURING THE PATIENT'S ECP TREATMENT. THE CUSTOMER REPORTED THAT THE PATIENT HAD AN EPISODE OF TACHYCARDIA AT THE TIME OF THIS ALARM WITH A PULSE OF 150. THE CUSTOMER STATED THAT THE PATIENT'S BLOOD PRESSURE AT THE TIME OF THIS ALARM WAS 73/51. THE CUSTOMER REPORTED THAT THE PATIENT WAS THEN ADMINISTERED 100 ML OF 20% ALBUMINE AND THE PATIENT FELT BETTER. THE CUSTOMER REPORTED THAT THERE WERE NO ALARMS DURING THE PRIMING OF THE CELLEX KIT AND NO OTHER ALARMS OCCURRED DURING THE PATIENT'S TREATMENT. THE CUSTOMER STATED THAT THE PATIENT WAS CONNECTED IN DOUBLE NEEDLE MODE WITH FLOW RATES OF 50 ML/MIN FOR COLLECTION AND 55 ML/MIN FOR RETURN. THE CUSTOMER REPORTED THAT AT THE TIME OF THE ALARM #19: FLUID BALANCE LIMIT ALARM, THE RETURN BAG WAS 3/4 FULL WITH THE PATIENT'S BLOOD. THE CUSTOMER STATED THAT AS SOON AS THE PATIENT'S FLUID BALANCE REACHED - 500 ML, THE PATIENT'S ECP TREATMENT PROCEDURE WAS CHANGED TO SINGLE NEEDLE MODE. THE CUSTOMER REPORTE

  Patient problems: Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 11891527 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED FAINTING AND HYPOTENSION DURING AN ECP TREATMENT PROCEDURE ON (B)(6) 2021. THE CUSTOMER STATED THAT ON THE DAY OF THE PATIENT'S ECP TREATMENT PROCEDURE, THEY STARTED THE PATIENT'S ECP TREATMENT A BIT LATER THAN EXPECTED. THE CUSTOMER REPORTED THAT THE PATIENT WAS ALREADY IN THE WARD FOR A LONG TIME AND DID NOT DRINK MUCH WATER. THE CUSTOMER STATED THAT THE ROOM WAS SMALL AND WARM AND MANY PEOPLE WERE PRESENT. THE CUSTOMER REPORTED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS PERFORMED IN DOUBLE NEEDLE MODE. THE CUSTOMER STATED THAT THERE WERE SEVERAL ALARM #16: COLLECT PRESSURE ALARMS DURING THE PATIENT'S ECP TREATMENT PROCEDURE DUE TO POOR VENOUS ACCESS. THE CUSTOMER REPORTED THAT THE ALARM #16: COLLECT PRESSURE ALARMS WERE RESOLVED WITH NORMAL TROUBLESHOOTING. THE CUSTOMER STATED THAT AT 1136ML OF WHOLE BLOOD PROCESSED THE PATIENT FAINTED. THE CUSTOMER REPORTED THAT THE PATIENT'S BLOOD PRESSURE AT THAT MOMENT WAS 60/30MMHG. THE CUSTOMER STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS THEN STOPPED AND A SALINE BOLUS WAS ADMINISTERED BY THE INSTRUMENT TO THE PATIENT. THE CUSTOMER REPORTED T

  Patient problems: Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 11414426 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED ARRHYTHMIA, NEUROLOGICAL FAILURE, OXYGEN DESATURATION, DOUBLE VISION, PARESTHESIA, MOVEMENT DISORDER, BLURRED VISION, AND THROMBOEMBOLISMS DURING AN ECP TREATMENT PROCEDURE ON (B)(6) 2021. THE CUSTOMER STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS RUN IN DOUBLE NEEDLE MODE WITH ACDA AS THE ANTICOAGULANT AT A RATIO OF 10:1. THE CUSTOMER REPORTED THAT 1500ML OF WHOLE BLOOD HAD BEEN PROCESSED DURING THE PATIENT'S ECP TREATMENT PROCEDURE AND THE PATIENT'S ACCESS WAS A DIALYSIS CENTRAL VENOUS ACCESS. THE CUSTOMER STATED THAT THE PATIENT WAS UNDERGOING THE FINAL BLOOD RETURN FOR THEIR ECP TREATMENT PROCEDURE WHEN THE PATIENT REPORTED THAT HE WAS NOT FEELING WELL. THE CUSTOMER REPORTED THAT THE PATIENT COMPLAINED OF A SHORT EPISODE OF SUBJECTIVE ARRHYTHMIA. THE CUSTOMER STATED THAT THE PATIENT'S PERIPHERAL OXYGEN SATURATION THEN DROPPED TO 85% FOR A FEW SECONDS. THE CUSTOMER REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE NEUROLOGICAL FAILURES. THE CUSTOMER STATED THAT AFTER A FEW MINUTES, THE PATIENT BEGAN TO SUFFER FROM DOUBLE VISION AND PARESTHESIA OF BOTH HIS ARMS AND BACK. THE CUSTOMER REPORTED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia; Blurred Vision; Embolism/Embolus; Low Oxygen Saturation; Movement Disorder; Paresthesia; Visual Impairment

  MAUDE report 11389010 ↗
• InjuryDec 21, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE DISTRIBUTOR REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED HYPOVOLEMIC SHOCK, OXYGEN DESATURATION, HYPOTENSION, BRADYCARDIA, AND FAINTED DURING AN ECP TREATMENT PROCEDURE ON (B)(6) 2020. THE DISTRIBUTOR STATED THAT THE PATIENT WAS BEING TREATED FOR LUNG GRAFT VERSUS HOST DISEASE AND ALWAYS HAS BREATHING PROBLEMS. THE DISTRIBUTOR REPORTED THAT THE PATIENT USED TO BE TIRED BEFORE HER ECP TREATMENT PROCEDURES. THE DISTRIBUTOR STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS IN DOUBLE NEEDLE MODE (DNM) WITH A COLLECT RATE OF 50ML/MIN, AND A RETURN RATE OF 40ML/MIN. THE DISTRIBUTOR REPORTED THAT THE PATIENT HAD NORMAL BLOOD PRESSURE AND OXYGEN SATURATION LEVELS PRIOR TO THEIR ECP TREATMENT PROCEDURE AND UP UNTIL THE BUFFY COAT EXTRACTION PHASE OF THEIR ECP TREATMENT PROCEDURE. THE DISTRIBUTOR REPORTED THAT DURING THE BUFFY COAT EXTRACTION PHASE, THE PATIENT EXPERIENCED HYPOVOLEMIC SHOCK. THE DISTRIBUTOR STATED THAT THE PATIENT'S OXYGEN SATURATION DROPPED TO 80%, AND THE PATIENT FAINTED. THE DISTRIBUTOR REPORTED THAT THE PATIENT ALSO EXPERIENCED HYPOTENSION, AND BRADYCARDIA WITH A HEART RATE OF 45. THE DISTRIBUTOR STATED THAT THE PATIENT'S FLUID BALANCE

  Patient problems: Bradycardia; Hypovolemic Shock; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Syncope/Fainting

  MAUDE report 11052697 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CALLED TO REPORT THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED CHEST PAIN, DIZZINESS, HYPOXIA, A THROMBOSIS, AND MULTIPLE PULMONARY EMBOLI A WEEK AFTER COMPLETING AN ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT HAD BEEN RECEIVING ECP TREATMENTS SINCE (B)(6) 2019 FOR CHRONIC GRAFT VERSUS HOST DISEASE (GVHD) WITH MOST RECENTLY THE PATIENT UNDERGOING TWO SEQUENTIAL DAYS OF ECP TREATMENTS EVERY OTHER WEEK. THE CUSTOMER REPORTED THAT THE PATIENT'S LAST ECP TREATMENT PROCEDURE WAS ON (B)(6) 2020 AND HEPARIN WAS USED AS THE ANTICOAGULANT FOR THIS TREATMENT PROCEDURE AT A 10:1 RATIO. THE CUSTOMER STATED THAT ON (B)(6) 2020, THE PATIENT WENT TO THE EMERGENCY ROOM WITH COMPLAINTS OF DIZZINESS. THE CUSTOMER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 DUE TO DIZZINESS AND HYPOXIA. THE CUSTOMER STATED THAT THE PATIENT WAS FOUND TO BE MILDLY HYPOXEMIC AS THE PATIENT REQUIRED TWO LITERS OF OXYGEN DELIVERED BY NASAL CANNULA IN ORDER TO MAINTAIN AN OXYGEN SATURATION OF GREATER THAN 94%. THE CUSTOMER REPORTED THAT THE PATIENT DID NOT EXHIBIT ANY SIGNS OF DYSPNEA NOR DID SHE HAVE ANY RESPIRATORY COMPLAINTS. THE CUSTOMER STATED T

  Patient problems: Chest Pain; Dizziness; Hypoxia; Pulmonary Embolism; Thrombosis

  MAUDE report 10151084 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED BOTH LOW HEMOGLOBIN AND A LOW PLATELET COUNT FOLLOWING A TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THEY HAD BEEN EXPERIENCING MULTIPLE ALARM #16: COLLECT PRESSURE AND ALARM #17: RETURN PRESSURE ALARMS. THE CUSTOMER REPORTED THAT THEY KEPT FLUSHING THE PATIENT'S VORTEX PORT ACCESS. THE CUSTOMER STATED THAT AT FIRST, THE PATIENT'S ACCESS FLUSHED WELL BUT THEN IT BECAME MORE DIFFICULT TO FLUSH. THE CUSTOMER REPORTED THAT THEY THEN STOPPED THE PATIENT'S ECP TREATMENT PROCEDURE AFTER 800 MLS OF WHOLE BLOOD HAD BEEN PROCESSED FOR ABOUT FIFTEEN MINUTES IN ORDER TO ADD TISSUE PLASMINOGEN ACTIVATOR (TPA) TO THE PATIENT'S ACCESS. THE CUSTOMER STATED THAT THE PATIENT'S ECP TREATMENT PROCEDURE WAS THEN RESUMED; HOWEVER THEY THEN NOTICED A CLOT IN THE KIT'S RETURN BAG. THE CUSTOMER REPORTED THAT THEY ABORTED THE PATIENT'S ECP TREATMENT PROCEDURE AFTER 1007 MLS OF WHOLE BLOOD PROCESSED AFTER THEY DISCOVERED A SECOND LARGE WHITE CLOT IN THE KIT'S CENTRIFUGE BOWL. THE CUSTOMER STATED THAT THEY ALSO NOTICED CLOTS IN THE KIT'S COLLECT LINE AS WELL. THE CUSTOMER REPORTED THAT NO CLOTS WERE OBSERVED IN THE KIT'S R

  Patient problems: Anemia; No Code Available

  MAUDE report 9211259 ↗
• InjurySep 22, 2019Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED MALAISE, COUGH, MUCUS, AND HYPOTENSION DURING A TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT WAS "NOT FULLY FIT" PRIOR TO HIS ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT WAS A LITTLE UNWELL THAT DAY AND IT WAS UNRELATED TO HIS ECP TREATMENT PROCEDURES. THE CUSTOMER REPORTED THAT THE PATIENT WAS COUGHING A LOT AND HE HAD A LOT OF MUCUS. THE CUSTOMER STATED THAT THE PATIENT WAS CURRENTLY ON AN ANTIBIOTICS TREATMENT FOR THESE SYMPTOMS. THE CUSTOMER REPORTED THAT THE PATIENT'S LABS WERE PERFORMED ON THE SAME DAY AS THE PATIENT'S TREATMENT; HOWEVER, NO ONE HAD CHECKED THE PATIENT'S LAB RESULTS OR MADE A DECISION ON WHETHER OR NOT HE SHOULD HAVE HAD A BLOOD TRANSFUSION PRIOR TO HIS ECP TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT'S PRE ECP HEMATOCRIT (HCT) READING WAS QUITE LOW, 26%, HIS HEMOGLOBIN (HGB) LEVEL WAS 8.4 G/DL, AND HIS BLOOD PRESSURE WAS 99/69. THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT AN ECP BLOOD PRIME TREATMENT PROCEDURE, WHICH WAS USUAL FOR THIS PATIENT. THE CUSTOMER STATED THAT THE PATIENT'S ECP BLOOD PRIME TREATMENT PROCEDURE STARTED

  Patient problems: Low Blood Pressure/ Hypotension; Malaise; No Code Available

  MAUDE report 9101840 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED MALAISE, DISCOMFORT, NUMBNESS, AND A CEREBROVASCULAR ACCIDENT (STROKE) FOLLOWING A TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT EXPERIENCED THE STROKE 12-16 HOURS AFTER THE SUCCESSFUL COMPLETION OF HIS ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT'S ECP TREATMENT PROCEDURE USED HEPARIN AS THE ANTICOAGULANT AT A 10:1 RATIO AND THIS TREATMENT WAS SUCCESSFULLY COMPLETED WITH BOTH BLOOD AND TREATED CELLS RETURNED TO THE PATIENT. THE CUSTOMER STATED THAT THERE WERE NO ALARMS DURING THE PATIENT'S ECP TREATMENT PROCEDURE AND NO CLOTTING WAS OBSERVED IN THE KIT. THE CUSTOMER REPORTED THAT THE PATIENT WAS ASYMPTOMATIC AFTER THE COMPLETION OF THEIR ECP TREATMENT PROCEDURE AND THE PATIENT HAD NO COMPLAINTS REGARDING NOT FEELING WELL EITHER BEFORE OR AFTER THE PROCEDURE THUS THE PATIENT WAS DISCHARGED HOME. THE CUSTOMER STATED THAT 12-16 HOURS AFTER THE PATIENT'S ECP TREATMENT PROCEDURE, THE PATIENT STARTED TO NOT FEEL WELL WHILE HE WAS AT HOME. THE CUSTOMER REPORTED THAT THE PATIENT FELT DISCOMFORT ON ONE SIDE OF HIS BODY. THE PATIENT STATED THAT HE HAD WOKEN IN ORDER TO USE THE

  Patient problems: Discomfort; Malaise; Numbness; Stroke/CVA

  MAUDE report 8801030 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) PATIENT EXPERIENCED WEAKNESS, DYSARTHRIA, AND A CEREBROVASCULAR ACCIDENT (STROKE) FOLLOWING A TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT EXPERIENCED LEFT-SIDE WEAKNESS AND DYSARTHRIA APPROXIMATELY THREE HOURS AFTER THE COMPLETION OF HIS ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT'S ECP TREATMENT PROCEDURE USED HEPARIN AS THE ANTICOAGULANT AT A 10:1 RATIO AND THIS TREATMENT WAS SUCCESSFULLY COMPLETED WITH BOTH BLOOD AND TREATED CELLS RETURNED TO THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT DID NOT HAVE ANY ISSUES OR COMPLAINTS PRIOR TO THEIR ECP TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY ADMITTED. THE CUSTOMER STATED THAT THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE WITH LEFT HEMIPARESIS (PARTIAL WEAKNESS ON ONE SIDE OF THE BODY), WHICH THE CUSTOMER FOUND ODD SINCE THE PATIENT NEVER HAD HIGH BLOOD PRESSURE. THE CUSTOMER REPORTED THAT THE PATIENT'S STROKE WAS CONFIRMED THROUGH PHYSICAL ASSESSMENTS, LAB TESTS AND A CT SCAN. THE CUSTOMER STATED THAT NO ACTUAL CLOTS WERE SEEN. THE CUSTOMER REPORTED THAT THERE WAS A

  Patient problems: No Code Available; Stroke/CVA; Weakness

  MAUDE report 8742025 ↗