Spectra Optia® 12220Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 05020583122208), received between Jun 9, 2021 and Sep 14, 2026 — classified as 14 deaths, 60 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (117 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Insufficient Device Problem Information

  Patient problems: Hemolysis

  MAUDE report 50762831 ↗
• InjuryAug 28, 2026Insufficient Device Problem Information

  Customer reported that after a Therapeutic plasma exchange (TPE) procedure the patient reqiured a platelet transfusion due to a drop in platelet count.  Per customer patient status "The patient's condition is unchanged, they are critical ICU level care." The Collection set is not available for return because it was discarded by the customer.

  Patient problems: Insufficient Information

  MAUDE report 50503148 ↗
• MalfunctionAug 14, 2026Insufficient Device Problem Information

  Patient problems: Hemolysis

  MAUDE report 50261925 ↗
• InjuryAug 6, 2026Insufficient Device Problem Information

  Customer reported that during a Red Blood Cell Exchange (RBCX) the patient experienced nausea, vomiting, diarrhea and low blood pressure. The procedure was stopped and the patient was given  50mg of IV Benadryl and 0.9% Normal Saline bolus IV. Patient status is stable The Collection set is not available for return because it was discarded by the customer.

  Patient problems: Diarrhea; Low Blood Pressure/ Hypotension; Nausea; Vomiting

  MAUDE report 50163235 ↗
• InjuryJul 20, 2026Insufficient Device Problem Information

  PER JOURNAL ARTICLE "PLASMA EXCHANGE WITH CORTICOSTEROIDS AS A RESCUE THERAPY FOR SEVERE PROLONGED CHOLESTASIS IN ACUTE VIRAL HEPATITIS" BY TANEJA, S., MEHTANI, R., GANESH, C. P., ROSE, S., BALARAJA, S., KANNUPRIYA, RATHI, S., DE, A., LAMBA, D., VERMA, N., PREMKUMAR, M., HANS, R., SHARMA, R. R., & DUSEJA, A. ABSTRACT: BACKGROUND AND AIMS:PROLONGED CHOLESTASIS AFTER ACUTE VIRAL HEPATITIS (AVH) COMPLICATES <1% OF PATIENTS. THE TREATMENT INCLUDES THE USE OF ANTI-PRURITIC MEDICATIONS IN A STEPWISE MANNER. THIS STUDY ASSESSED THE ROLE OF PLASMA EXCHANGE (PLEX) WITH CORTICOSTEROIDS ON SEVERE PROLONGED CHOLESTASIS.METHODS:RETROSPECTIVE ANALYSIS OF PATIENTS WITH AVH AND PROLONGED CHOLESTASIS WAS CONDUCTED. PROLONGED CHOLESTASIS WAS DEFINED AS JAUNDICE FOR >6 WEEKS WITH PEAK SERUM BILIRUBIN >10 MG/DL, IN THE ABSENCE OF HAEMOLYSIS AND RENAL FAILURE WITH ALANINE TRANSFERASE LEVEL BELOW 500U/L. A COMBINATION OF CENTRIFUGAL PLEX WITH CORTICOSTEROIDS WAS OFFERED IF THERE WAS NO RESPONSE TO ANTI-PRURITIC MEDICATIONS. A CONTROL GROUP, WHICH RECEIVED ONLY ANTI-PRURITIC MEDICATIONS, WAS INCLUDED FOR COMPARISON.RESULTS:FIFTY-NINE PATIENTS, PREDOMINANTLY MALES (90%; N = 53) WERE INCLUDED. MOST COMMON

  Patient problems: Adult Respiratory Distress Syndrome

  MAUDE report 25883535 ↗
• InjuryJul 16, 2026Insufficient Device Problem Information

  PER JOURNAL ARTICLE "PERIPHERAL VENOUS ACCESS FOR LOW-VOLUME CENTRIFUGAL PLASMA EXCHANGE TO TREAT PATIENTS WITH LIVER DISORDERS" BY JANEELA, A. M., CHELLAIYA, G. K., THOMAS, R., BANSAL, A., KUMAR, S., SUNDERRAJ, G., JAYARAMAN, S., KUMAR, S. E., ALEXANDER, V., DAVID, V. G., VARUGHESE, S., DANIEL, D., NAIR, S. C., EAPEN, C. E., GOEL, A., & ZACHARIAH, U. G. BACKGROUND/AIMS: CENTRIFUGAL PLASMA EXCHANGE (PLEX), BY VIRTUE OF LOW BLOOD FLOW RATES, CAN BE PERFORMED VIA PERIPHERAL VENOUS ACCESS. THIS STUDY AIMS TO ASSESS THE UTILIZATION, SAFETY, AND EFFICIENCY OF LOW-VOLUME CENTRIFUGAL PLASMA EXCHANGE VIA PERIPHERAL VENOUS ACCESS (P-PLEX)IN LIVER DISEASE PATIENTS. METHODS: THIS RETROSPECTIVE COHORT STUDY COMPARED PATIENTS WITH LIVER DISEASE WHO UNDERWENT LOW-VOLUME CENTRIFUGAL P-PLEX (2019¿2024) WITH SYNDROME-MATCHED PATIENTS WHO UNDERWENT PLASMA EXCHANGE VIA CENTRAL VENOUS ACCESS (C-PLEX). DATA ON PLEX PROCEDURE, VENOUS ACCESS, AND EXTRACTION EFFICIENCY FOR MOLECULES OF INTEREST WERE NOTED. RESULTS: OF 448 LIVER DISEASE PATIENTS WHO UNDERWENT CENTRIFUGAL LOW-VOLUME PLEX, 81 PATIENTS (18.1%) WHO UNDERWENT P-PLEX (M: 60; AGE: 37 "[29.5¿46.5]" YEARS; MEDIAN, INTERQUARTILE RANGE) WERE COMPARED

  Patient problems: Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 25843289 ↗
• MalfunctionApr 2, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE ON AN OPTIA DEVICE THE SYSTEM ALARMED CONTINUED TO DETECT CELLS IN PLASMA LINE AND HAD "ORANGE PLASMA". THE OPERATOR CHECKED THE GREEN LINE WAS ATTACHED TO 0.9% NORMAL SALINE, ORANGE LINE WAS ATTACHED TO ACD-A, REPLACEMENT SPIKES WERE ATTACHED TO THE FRESH FROZEN PLASMA. THE PHYSICIAN WANTED THE PROCEDURE ABORTED AND COULDN'T GIVE A REASON FOR THE "ORANGE PLASMA." THERE WAS NO MEDICAL INTERVENTION. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hemolysis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767601 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A FIFTH RUN ON OF EXCHANGE PROCEDURE ALARM 4537, "CELLS DETECTED IN THE PLASMA TUBE COMING FROM THE CENTRIFUGE," WAS DISPLAYED. THE DETECTOR WAS CHECKED FOR AIR BUBBLES; THERE WERE NO BLOCKAGES OR CLOTS AND THE ENTERED HEMATOCRIT WAS CHECKED AND WAS CORRECT. HEMOLYSIS WAS CONFIRMED. THE ATTENDING PHYSICIAN PERFORMED A MANUAL EXCHANGE USING THE BOLUS FUNCTION. 1100ML WERE WITHDRAWN FROM THE PATIENT USING A SYRINGE, AND 850 ML OF PACKED RED BLOODCELLS WERE ADMINISTERED VIA THE SPECTRA OPTIA BOLUS FUNCTION AND AN ADDITIONAL 200 ML OF PACKED RED BLOOD CELLS WERE ADMINISTERED DIRECTLY VIA THE CATHETER. PER CUSTOMER "THE PATIENT STABILIZED DURING THE MANUAL EXCHANGE." THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hemolysis

  MAUDE report 24717466 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A SECOND RUN ON OF EXCHANGE PROCEDURE COAGULATIONS WERE FOUND IN THE WASTE BAG. A UNIT OF PACKED RED BLOOD CELLS WAS ADMINISTERED TO THE PATIENT VIA BOLUS AFTER WHICH THE RUN WAS ABORTED WITHOUT BLOOD RETURN. PER CUSTOMER "THE PATIENT STABILIZED DURING THE MANUAL EXCHANGE." THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717404 ↗
• MalfunctionJan 9, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE THEY OBSERVED HEMOLYSIS AT THE INITIATION OF THE RUN IN THE CONNECTOR. NORMAL SALINE AND ACDA WERE ATTACHED AND BOTH SOLUTIONS WERE CORRECTLY ATTACHED. NO CLOTS WERE OBSERVED IN THE CHANNEL. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS ASYMPTOMATIC. PATIENT OUTCOME STABLE THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hemolysis

  MAUDE report 24022029 ↗
• DeathJan 7, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "OUTCOMES OF THERAPEUTIC PLASMA EXCHANGE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA CAST NEPHROPATHY" BY DIMA, D., GOEL, U., SANNAREDDY, A., ET AL ABSTRACT: CURRENT TREATMENT GUIDELINES OF MYELOMA CAST NEPHROPATHY (MCN) RECOMMEND THE INSTITUTION OF PLASMA CELL-DIRECTED THERAPY AND CONSIDERATION OF THERAPEUTIC PLASMA EXCHANGE (TPE), WITH THE GOAL OF RAPID REDUCTION OF THE SERUM FREE LIGHT CHAIN (SFLC). HOWEVER, THE ROLE OF TPE CONTINUES TO REMAIN A SUBJECT OF DEBATE. THE GOAL OF THIS RETROSPECTIVE BI-INSTITUTIONAL STUDY WAS TO EVALUATE THE CLINICAL OUTCOMES OF TPE IN COMBINATION WITH SYSTEMIC THERAPY. EIGHTY PATIENTS WERE INCLUDED IN THIS ANALYSIS, OF WHOM 72.5% HAD =50% DROP IN THEIR INITIAL INVOLVED SFLC. AT 3 MONTHS FROM TPE INITIATION, THE OVERALL HEMATOLOGIC RESPONSE RATE (ORR) WAS 67.5% WITH A VERY GOOD PARTIAL RESPONSE OR BETTER (=VGPR) RATE OF 40%. AT 6 MONTHS, ORR WAS 57.5%, WITH =VGPR RATE OF 49%. THE RENAL RESPONSE RATE AT 3 AND 6 MONTHS WAS 47.5% AND 43.75%, RESPECTIVELY; THE OVERALL RENAL RESPONSE RATE WAS 48.75%. ON MULTIVARIABLE ANALYSIS, EVERY ONE UNIT INCREASE IN BASELINE CREATININE (ODDS RATIO "[OR]" 0.76, P = 0.006), AND ACHIEVEMENT OF

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993790 ↗
• MalfunctionJan 5, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A RED BLOOD CELL EXCHANGE (RBCX) PROCEDURE THEY OBSERVED HEMOLYSIS AT THE BEGINNING OF THE RUN IN THE CONNECTOR. NORMAL SALINE, ACDA, AND PRBCS WERE ATTACHED AND ALL THE SOLUTIONS WERE ATTACHED CORRECTLY. PER CUSTOMER PATIENT STATUS "BASELINE" AND NO MEDICAL INTERVENTION OCCURRED. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hemolysis

  MAUDE report 23959597 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER THE JOURNAL ARTICLE: "REAL-WORLD SAFETY DATA FROM THE WORLD APHERESIS ASSOCIATION REGISTRY FOR THE SPECTRA OPTIA APHERESIS SYSTEM" BY A. HAUBNER ET AL. IT WAS FOUND IN THIS STUDY WE ANALYZED 12 YEARS OF ADVERSE EVENTS, (AE) DATA FROM THE WORLD APHERESIS ASSOCIATION, (WAA) REGISTRY SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM. WE QUERIED WAA REGISTRY DATA, (2012¿2023) ON APHERESIS PROCEDURES PERFORMED EXCLUSIVELY ON THE SPECTRA OPTIA APHERESIS SYSTEM. WE CATEGORIZED AES BY SEVERITY, (MILD, MODERATE, AND SEVERE), AND ORDERED THEM BY YEAR. WE THEN ANALYZED AND PRESENTED AES ASSOCIATED WITH THE FOLLOWING VARIABLES: DIAGNOSIS, PROCEDURE TYPE, VASCULAR ACCESS, AND REPLACEMENT FLUID TYPE, AND CAUSES OF PROCEDURAL INTERRUPTION. WE IDENTIFIED 51 567 APHERESIS PROCEDURES SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM WITHIN THE DATA SET. AE RATES FROM 2012 TO 2023 FOR MILD, MODERATE, AND SEVERE WERE 1.43%, 2.81%, AND 0.21%, RESPECTIVELY. PROCEDURES ASSOCIATED WITH THE LOWEST AE RATES INCLUDE RED BLOOD CELL EXCHANGE AND THERAPEUTIC PLASMA EX CHANGE. THE MOST COMMON MILD AND MODERATE AES INCLUDE TINGLING AND HYPOTENSION AND AES RELATED TO VASCULAR ACCESS. THE HIGHEST RATES OF MILD AND MO

  Patient problems: Abdominal Pain; Chills; Fever; Low Blood Pressure/ Hypotension; Nausea; Urticaria; Vomiting

  MAUDE report 23865570 ↗
• DeathDec 22, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER THE JOURNAL ARTICLE: "REAL-WORLD SAFETY DATA FROM THE WORLD APHERESIS ASSOCIATION REGISTRY FOR THE SPECTRA OPTIA APHERESIS SYSTEM" BY A. HAUBNER ET AL. IT WAS FOUND IN THIS STUDY WE ANALYZED 12 YEARS OF ADVERSE EVENTS, (AE) DATA FROM THE WORLD APHERESIS ASSOCIATION, (WAA) REGISTRY SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM. WE QUERIED WAA REGISTRY DATA, (2012¿2023) ON APHERESIS PROCEDURES PERFORMED EXCLUSIVELY ON THE SPECTRA OPTIA APHERESIS SYSTEM. WE CATEGORIZED AES BY SEVERITY, (MILD, MODERATE, AND SEVERE), AND ORDERED THEM BY YEAR. WE THEN ANALYZED AND PRESENTED AES ASSOCIATED WITH THE FOLLOWING VARIABLES: DIAGNOSIS, PROCEDURE TYPE, VASCULAR ACCESS, AND REPLACEMENT FLUID TYPE, AND CAUSES OF PROCEDURAL INTERRUPTION. WE IDENTIFIED 51 567 APHERESIS PROCEDURES SPECIFIC TO THE SPECTRA OPTIA APHERESIS SYSTEM WITHIN THE DATA SET. AE RATES FROM 2012 TO 2023 FOR MILD, MODERATE, AND SEVERE WERE 1.43%, 2.81%, AND 0.21%, RESPECTIVELY. PROCEDURES ASSOCIATED WITH THE LOWEST AE RATES INCLUDE RED BLOOD CELL EXCHANGE AND THERAPEUTIC PLASMA EX CHANGE. THE MOST COMMON MILD AND MODERATE AES INCLUDE TINGLING AND HYPOTENSION AND AES RELATED TO VASCULAR ACCESS. THE HIGHEST RATES OF MILD AND MO

  Patient problems: Myocardial Infarction

  MAUDE report 23865566 ↗
• InjuryDec 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING AN EXCHANGE PROCEDURE ON A PEDIATRIC PATIENT THE RED SALINE ROLLER CLAMP POPPED OFF THE LINE AND BLOOD BACKED UP INTO THE SALINE BAG. THE ECMO TEAM THEN TOLD THE APHERESIS OPERATOR IT HAD POPPED OFF DURING CONNECTING THE LINE TO THE ECMO CIRCUIT. THE ENDING FLUID BALANCE WAS REPORTED AS 100%. THE CUSTOMER REPORTED A BLOOD TRANSFUSION DUE TO A DROP IN HEMATOCRIT. THE PATENT WAS REPORTED AS HAVING EVANS SYNDROME AND UNSTABLE IN THE INTENSIVE CARE UNIT. PATIENT WAS CONNECTED TO ECMO AND CRRT. THE PATIENT WAS GIVEN CALCIUM GLUCONATE 2,400 MG IV GIVEN THROUGHOUT THE PROCEDURE. THE EXCHANGE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Anemia; Insufficient Information

  MAUDE report 23842568 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED AND THEY HAD LOW CALCIUM DURING AN EXCHANGE PROCEDURE. THE PATIENT WAS GIVEN 40ML OF CALCIUM PURE SLOWLY PUT AND LEVOPHED 8 MG+125 DW PATIENT STATUS PER CUSTOMER IS "STABLE" THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23695047 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "ROLE OF HIGH-VOLUME PLASMAPHERESIS IN THE MANAGEMENT OF PEDIATRIC ACUTE LIVER FAILURE " BY JOHANNES HILBERATH / VITTORIA CAMELLI / CHRISTIANE HOFER /STEFFEN HARTLEIF / SILVIO NADALIN / MAREN PETERS / MATTHIAS KUMPF / ANDREA BEVOT / MATTHIAS ZIRNGIBL / MARCUS WEITZ / EKKEHARD STURM OBJECTIVES: PAEDIATRIC ACUTE LIVER FAILURE (PALF) IS A LIFE-THREATENING DISEASE. MANAGEMENT AIMS TO SUPPORT HEPATIC REGENERATION OR TO BRIDGE TO LIVER TRANSPLANTATION. HIGH-VOLUME PLASMAPHERESIS (HVP) REMOVES PROTEIN-BOUND SUBSTANCES, ALLEVIATES INFLAMMATION, AND IMPROVES SURVIVAL IN ADULT ACUTE LIVER FAILURE. HOWEVER, EXPERIENCE WITH HVP IN PALF IS LIMITED. AIM OF THIS STUDY IS TO REPORT ON FEASIBILITY, SAFETY, EFFICACY AND OUTCOMES OF HVP IN PALF. METHODS: RETROSPECTIVE OBSERVATIONAL STUDY IN CHILDREN WITH PALF. HVP WAS PERFORMED UPON IDENTIFICATION OF NEGATIVE PROGNOSTIC INDICATORS, IN TOXIC AETIOLOGY OR MULTIORGAN FAILURE (MOF). EXCHANGED VOLUME WITH FRESH-FROZEN PLASMA CORRESPONDED TO 1.5¿2.0 TIMES THE PATIENT'S ESTIMATED PLASMA VOLUME. ONE DAILY CYCLE WAS PERFORMED UNTIL THE PATIENT MET CRITERIA FOR DISCONTINUATION, THAT IS, LIVER REGENERATION, LIVER TRANSPLANTATION, OR DEATH. R

  Patient problems: Hemolysis

  MAUDE report 23632362 ↗
• MalfunctionNov 24, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "THE ROLE OF PLASMAPHERESIS IN SEVERE ACUTE DISSEMINATED ENCEPHALOMYELITIS WITH CLINICAL FINDINGS OF TRANSVERSE MYELITIS. THERAPEUTIC APHERESIS AND DIALYSIS" BY FJELLBIRKELAND, O. W., SZPIRT, W. M., & BØRRESEN, M. L. THREE LITERS OF PLASMA WERE REMOVED (58 ML PLASMA/KG WEIGHT) AND REPLACED WITH A REPLACEMENT FLUID CONSISTING OF 20% HUMAN ALBUMIN AND RINGER'S ACETATE (RATIO 1:4) USING THE SPECTRA OPTIA SYSTEM. EACH EXCHANGE PROCEDURE WAS COMPLETED WITHIN 90 MIN. THE FIRST TWO SESSIONS WERE PERFORMED DAILY FOLLOWED BY THREE EVERY OTHER DAY. IMMEDIATELY FOLLOWING THE FIRST PROCEDURE, THE PATIENT EXPERIENCED MODERATE HYPOTENSION (BLOOD PRESSURE 89/49). NO FURTHER COMPLICATIONS FOLLOWING THE REMAINING PROCEDURES WERE OBSERVED. THE PATIENT RECEIVED HDMP FOR AN ADDITIONAL 3 DAYS, FOLLOWED BY 7 DAYS OF 75 MG ORAL PREDNISOLONE. PER JOURNAL ARTICLE "A MONTH AFTER DISCHARGE, THE PATIENT WAS STILL RECOVERING. SHE HAD REGAINED NORMAL MOTOR FUNCTION BUT SUFFERED FROM FATIGUE, POOR CONCENTRATION, AND HEADACHES. AN MRI WAS PERFORMED 5 WEEKS AFTER THE INDEX ATTACK AND DEMONSTRATED COMPLETE RESOLUTION OF THE ABNORMALITIES. DURING 3 MONTHS, THE DOSE OF PREDNISONE WAS GRADUALLY RED

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23632043 ↗
• MalfunctionOct 29, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT AFTER A SICKLE CELL PATIENT UNDERWENT A RED CELL EXCHANGE PROCEDURE THEIR PLATELET COUNT DECREASED BY 97 PERCENT (THE EXPECTED DROP RANGE IS 30-50 PERCENT). PRIOR TO THE PROCEDURE THE PATIENT'S PLATELET COUNT WAS 229 X 10^9/L AS ON (B)(6) 2025, BUT AFTER THE PROCEDURE ON (B)(6) 2025 THEIR PLATELET COUNT WAS 7 X 10^9/L. THE PATIENT THEN RETURNED THE FOLLOWING NIGHT ON (B)(6) 2025) FOR A PLATELET CHECK WHICH SHOWED A PLATELET COUNT OF 80 X 10^9/L. PER THE APHERESIS NURSING TEAM'S ASSESSMENT OF THE SITUATION NOTHING ABNORMAL HAD OCCURRED. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415833 ↗
• DeathOct 23, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT AT THE END OF A PLASMA EXCHANGE PROCEDURE WITH A POSTPARTUM PATIENT DIAGNOSED WITH DEVIC SYNDROME THE PATIENT SUFFERED DIARRHEA, SEVERE HYPOTENSION, NAUSEA, VOMITING, ALTERED MENTAL STATUS, CRAMPS, AND CHEST PAIN (NORMAL ECG). LABORATORY TESTS SHOWED SEVERE METABOLIC ACIDOSIS. THE PATIENT THEN BECAME STUPOROUS AND DESATURATED. VASOPRESSORS WERE INITIATED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. POOR RESPIRATORY MECHANICS. OROTRACHEAL INTUBATION WAS PERFORMED, FOLLOWED BY RESUSCITATION WITH CRYSTALLOIDS, VASOPRESSORS, AND ANTIBIOTICS FOR POST-PROCEDURE DIARRHEA. WITH A POOR OUTCOME. CARDIAC ARREST AND DEATH OCCURRED ON THE (B)(6) 2025. THE PATIENT WAS GIVEN PREPLANNED MEDICATIONS OF: CALCIUM GLUCONATE, VASOPRESSORS, AND ANTIBIOTICS. THE DEATH NOTE/SUMMARY INDICATED THAT THE PATIENT EXPIRED AS AN EVOLUTION OF INTENSIVE THERAPY. THE PHYSICIAN¿S OPINION ON THE CAUSE OF DEATH WAS DUE TO SEPTIC SHOCK WITH PROBABLE ABDOMINAL FOCUS VERSUS PROGRESSION OF UNDERLYING DISEASE; HOWEVER NO AUTOPSY WAS PERFORMED. FURTHER FOLLOW UP WITH THE CUSTOMER RECEIVED ON THE 6TH OF NOVEMBER INDICATED THAT THE CAUSE OF DEATH WAS NOT SUSPECT TO THE DEVICE. ADDITIONAL

  Patient problems: Cramp(s) /Muscle Spasm(s); Diarrhea; Loss of consciousness; Low Blood Pressure/ Hypotension; Nausea; Vomiting

  MAUDE report 23367972 ↗
• MalfunctionSep 5, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT DURING AN ERYTHROCYTE EXCHANGE THEY VISUALLY OBSERVED AN ABNORMAL PRESENCE OF AIR, AT LEAST A FEW MILLILITERS, IN THE SALINE TUBING LOCATED ON THE RETURN LINE TO THE PATIENT AT WHICH POINT THE PROCEDURE WAS IMMEDIATELY INTERRUPTED. PER THE CUSTOMER, THE CDS PHYSICIAN WAS PRESENT, AND THE IETS STAFF AND PRESCRIBING PHYSICIAN WERE PROMPTLY NOTIFIED. PATIENT INFORMATION IS UNKNOWN AT THIS TIME. PER CUSTOMER "THE NECESSARY CARE/TESTING AND PATIENT MONITORING WERE PERFORMED. NO PATIENT COMPLICATIONS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977898 ↗
• MalfunctionSep 4, 2025Crack; Leak/Splash; Device Contamination with Body Fluid; Therapeutic or Diagnostic Output Failure

  WE HAD THREE SPECTRA OPTIA APHERESIS SYSTEM SET UPS MALFUNCTION AND NEEDED REPLACED. I CONTACTED SPECTRA ON [DATE REDACTED] THE TUBING CRACKED INSIDE CENTRIFUGE AND SPRAYED BLOOD INSIDE MACHINE. SPECTRA STATED A TECH WOULD COME OUT TO CLEAN MACHINE AND THEY WOULD COMPENSATE OUR FACILITY FOR THE FAULTY EQUIPMENT. SINCE THEN, WE HAD ANOTHER SET UP FAIL LOT NUMBER 2503103341 RED 12220 EXPIRE 2027-03-01 AND A THIRD SET UP LOT NUMBER 2502183141 REF 12220 EXPIRES 2027-02-01. THESE LAST TWO FAILURES WERE CAUGHT DURING SET UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962993 ↗
• MalfunctionAug 29, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT DURING A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE THEY HAD A "CELLS DETECTED IN PLASMA LINE FROM CENTRIFUGE" ALARM AND REPORTED HEMOLYSIS. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hemolysis

  MAUDE report 22922980 ↗
• MalfunctionAug 28, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER ALLEGED MEDICAL INTERVENTION BUT DID NOT PROVIDE ADDITIONAL DETAILS. THE FOLLOWING DETAILS OF THE PROCEDURE WERE PROVIDED, AT THE BEGINNING OF THE PRIMING OF THE TUBING (WITH THE BLOOD), THE FOLLOWING ALARM WAS TRIGGERED: THE CELL CONCENTRATION IN THE PLASMA TUBING WAS HIGHER THAN EXPECTED ALARM. THE DOCTOR INCREASED THE TARGET HEMATOCRIT, BUT IT DIDN'T WORK. THE MACHINE WAS CHANGED USING THE SAME DATA: THE EXCHANGE WAS COMPLETED WITHOUT INCIDENT. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914020 ↗
• InjuryAug 25, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "REPORT OF THE ASFA APHERESIS REGISTRY STUDY ON FOCAL SEGMENTAL GLOMERULOSCLEROSIS" BY POYYAPAKKAM SRIVATHS, GRACE F. MONIS, LEONOR P. FERNANDO, JEANNE E. HENDRICKSON, JAY S. RAVAL, CYRIL JACQUOT, KEEFE DAVIS, EDWARD WONG, CHISA YAMAD ABSTRACT FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) IS ONE OF THE CAUSES OF END-STAGE KIDNEY DISEASE. THE ETIOLOGY IS NOT FULLY UNDERSTOOD, AND STANDARDIZED TREATMENTS ARE NOT ESTABLISHED. WE CREATED A REGISTRY ON APHERESIS FOR POST-TRANSPLANT FSGS THROUGH THE RENAL SUBCOMMITTEE IN THE RESEARCH COMMITTEE IN THE AMERICAN SOCIETY FOR APHERESIS (ASFA), AND HERE IS OUR FIRST REPORT. MEMBERS OF THE RENAL SUBCOMMITTEE FROM SEVEN CENTERS IN THE UNITED STATES CONTRIBUTED DATA COLLECTION ON DEMOGRAPHIC, CLINICAL COURSE, AND OVERALL OUTCOMES OF PATIENTS WITH POST-TRANSPLANT RECURRENCE OF FSGS TREATED WITH THERAPEUTIC PLASMA EXCHANGE (TPE) BETWEEN 2015 AND 2020. THE TPE DATA, INCLUDING FREQUENCY AND REPLACEMENT FLUID FOR TPE, ARE ALSO INVESTIGATED. THE MEDIAN AGE AT DIAGNOSIS OF FSGS AND FIRST TRANSPLANTATION AMONG 26 PATIENTS WAS 12.7 AND 21 YEARS, RESPECTIVELY. THE FSGS RECURRED AT A MEDIAN OF 1 DAY AFTER TRANSPLANTATION, AND TPE WAS PERFORM

  Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885475 ↗