Spectra Optia® 12120Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05020583121201), received between Aug 21, 2018 and Sep 30, 2024 — classified as 10 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) ON A SPECTRA OPTIA DEVICE, THE RESERVOIR BECAME FOAMY, AND THE RETURN PUMP WAS POTENTIALLY DEFECTIVE. PER THE CUSTOMER, THE DEVICE ALARMED "FOAM IN THE RESERVOIR". MEDICAL INTERVENTION WAS REPORTED, BUT IT IS UNKNOWN AT THIS TIME WAS REQUIRED. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

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

  MAUDE report 20334375 ↗
• InjurySep 3, 2024Adverse 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 "SMALL BUT MIGHTY: CASE REPORT AND PRACTICAL GUIDANCE FOR PERIPHERAL BLOOD STEM CELL COLLECTION IN SMALL INFANTS", BY WALKER, H., O¿REILLY, E., MILLARD, Z., CUSACK, B., DUNCAN, A., CLUCAS, L., FLEMING, J., HUGHES, D., GREENWAY, A., & METZ, D., PATIENT A WAS DIAGNOSED WITH AN ATYPICAL TERATOID RHABDOID TUMOR, A CENTRAL NERVOUS SYSTEM (CNS) TUMOR, AT APPROXIMATELY FOUR MONTHS OF AGE AFTER PRESENTING WITH VOMITING AND FAILURE TO THRIVE. THE INFANT WAS REFERRED TO THE APHERESIS SERVICE FOR PERIPHERAL STEM CELL MOBILIZATION AND COLLECTION IN 2022, WEIGHING 5 KG. ON DAY 1 OF COLLECTION, OPTIA SYSTEM RECOMMENDED RUN VALUES WERE USED, WITH EXCEPTION OF THE OPERATOR MANUALLY ADJUSTING (INCREASING) THE ANTICOAGULATION (AC) INFUSION RATE TO 0.9 ML/MIN/L TOTAL BLOOD VOLUME (TBV), ALLOWING AN INLET FLOW RATE TO 5 ML/MIN AS REQUIRED FOR CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) PROCEDURE AS PER THE OPERATOR'S MANUAL. THE INLET:AC RATIO WAS 12:1 AND THE COLLECT FLOW RATE WAS 0.5 ML/MIN. BLOOD WARMER TUBING (25 ML) WAS ADDED TO THE CIRCUIT. DURING COLLECTION, THE INFANT WAS UNSETTLED, AND WITH PERSISTENT SINUS TACHYCARDIA. INTERVENTIONS INCLUDED PARACETAMOL, INCREASING THE

  Patient problems: Tachycardia

  MAUDE report 20128416 ↗
• InjurySep 3, 2024Adverse 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 "SUCCESSFUL STEM CELL APHERESIS USING SPECTRA OPTIA IN A 6¿KG CHILD WITH ATYPICAL TERATOID/RHABDOID TUMOR" BY PATRICK BRUST, CLAUDIA SCHUBERT, MARTIN BLOHM, AND BEATE WINKLER, SUMMARY: PERIPHERAL BLOOD STEM CELL APHERESIS HAS BECOME A ROUTINE PROCEDURE FOR THE COLLECTION OF PERIPHERAL BLOOD STEM CELLS TO ENABLE HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN HIGH-RISK PEDIATRIC MALIGNANCIES. HOWEVER, THE PROCEDURE REMAINS CHALLENGING IN VERY LOW-WEIGHT INFANTS DUE TO HIGH EXTRACORPOREAL BLOOD VOLUME AND CITRATE TOXICITY. OUR CASE REPORT DEMONSTRATES IN DETAIL A SUCCESSFUL AND COMPLICATION-FREE LARGEVOLUME LEUKAPHERESIS IN A VERY SMALL INFANT WEIGHING 6 KG USING A SPECTRA OPTIA APHERESIS SYSTEM AFTER PLACING A FEMORAL DOUBLELUMEN SHALDON CATHETER. ANTICOAGULATION WAS ACHIEVED BY CITRATE DEXTROSE SOLUTION WITHOUT THE USE OF HEPARIN. THE TOTAL AMOUNT OF BLOOD BEING PROCESSED DURING THE PROCEDURE EQUALED ALMOST 4 TIMES THE TOTAL BLOOD VOLUME OF THE PATIENT. THE FINAL APHERESIS PRODUCT CONTAINED 14.0×106 CD34+ CELLS/KG BODY WEIGHT. THE INFANT WAS DIAGNOSED WITH AN ATYPICAL TERATOID/RHABDOID TUMOR OF THE THALAMUS AND THIRD VENTRICLE AT THE A

  Patient problems: Fever

  MAUDE report 20127264 ↗
• MalfunctionSep 3, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "ENGRAFTMENT AFTER AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION IN PATIENTS MOBILIZED WITH PLERIXAFOR: A RETROSPECTIVE, MULTICENTER STUDY OF A LARGE SERIES OF PATIENTS", BY, ANTELO, M. L., ALTUNA, A., GIMENO, J. J., FERREIRO, J. J., AMUNÁRRIZ, C., MATEOS, J. J., ZALBA, S., ALKORTA, A., RIFÓN, J., ARROYO, J. L., URESANDI, A., MORENO, J. A., NÁJERA, M. J., PINZÓN, S., GARCÍA, A., VALLEJO, J. C.. ABSTRACT PLERIXAFOR (PLX) APPEARS TO EFFECTIVELY ENHANCE HEMATOPOIETIC STEM-CELL MOBILIZATION PRIOR TO AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HCT). HOWEVER, THE QUALITY OF ENGRAFTMENT FOLLOWING AUTO-HCT HAS BEEN LITTLE EXPLORED. HERE, ENGRAFTMENT FOLLOWING AUTO-HCT WAS ASSESSED IN PATIENTS MOBILIZED WITH PLX THROUGH A RETROSPECTIVE, MULTICENTER STUDY OF 285 CONSECUTIVE PATIENTS. INFORMATION ON EARLY AND 100-DAY POST-TRANSPLANT ENGRAFTMENT WAS GATHERED FROM THE 245 PATIENTS THAT UNDERWENT AUTO-HCT. THE MEDIAN NUMBER OF PLX DAYS TO REACH THE STEM CELL COLLECTION GOAL (=2 × 106 CD34+ CELLS/KG) WAS 1 (RANGE 1¿4) AND THE MEDIAN PLX ADMINISTRATION TIME BEFORE APHERESIS WAS 11 H (RANGE 1¿18). THE MEDIAN NUMBER OF APHERESIS SESSIONS TO ACHIEVE THE COLLECTIO

  Patient problems: Abdominal Pain; Diarrhea

  MAUDE report 20126858 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE ON A SPECTRA OPTIA DEVICE, THE OPERATOR SET THE PLASMA COLLECTION TARGET TO 500 ML AND THE DEVICE ATTEMPTED TO COLLECT 1 L OF PLASMA FROM THE PATIENT. PER THE CUSTOMER, AFTER THE DEVICE FINISHED COLLECTING 500 ML OF PLASMA, THE RBC VALVE OPENED AND BEGAN TO PUMP PLASMA INTO THE NMC COLLECTION BAG. IT WAS REPORTED THAT THE PROCEDURE STOPPED, AND THE OPERATOR CHECKED THE TARGET PLASMA ON THE MAIN SCREEN AND THE DEVICE SHOWED THAT THE PLASMA TARGET WAS NOW 1000 ML. PER THE CUSTOMER, THE DEVICE ALARMED "LEAK DETECTED". THE CUSTOMER INDICATED THAT THERE WAS NO INJURY OR MEDICAL INTERVENTION FOR THIS EVENT. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. 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 19538013 ↗
• MalfunctionJun 14, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE ON A SPECTRA OPTIA DEVICE, THE OPERATOR SET THE PLASMA COLLECTION TARGET TO 500 ML AND THE DEVICE ATTEMPTED TO COLLECT 1 L OF PLASMA FROM THE PATIENT. PER THE CUSTOMER, AFTER THE DEVICE FINISHED COLLECTING 500 ML OF PLASMA, THE RBC VALVE OPENED AND BEGAN TO PUMP PLASMA INTO THE NMC COLLECTION BAG. IT WAS REPORTED THAT THE PROCEDURE STOPPED, AND THE OPERATOR CHECKED THE TARGET PLASMA ON THE MAIN SCREEN AND THE DEVICE SHOWED THAT THE PLASMA TARGET WAS NOW 1000 ML. PER THE CUSTOMER, THE DEVICE ALARMED "LEAK DETECTED". THE CUSTOMER INDICATED THAT THERE WAS NO INJURY OR MEDICAL INTERVENTION FOR THIS EVENT. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. 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 19537850 ↗
• InjuryMar 21, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "CHARACTERISTICS OF AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS COLLECTION OVER A ONE-YEAR PERIOD" BY AHMETOVIC-KARIC, ET ALAHMETOVIC-KARIC, G., CATOVIC-BARALIJA, E., SOFO-HAFIZOVIC, A.. A RETROGRADE ANALYSIS OF 24 LEUKAPHERESIS IN 20 ADULT PATIENTS WITH MALIGNANT HEMATOLOGICAL DISEASES IN THE BLOOD TRANSFUSION INSTITUTE OF THE FEDERATION OF BOSNIA AND HERZEGOVINA IN SARAJEVO, WAS DONE. CELL SEPARATORS AMICUS AND SPECTRA OPTIA WERE USED FOR COLLECTION PROCEDURES. RESULTS THE PATIENT¿S AGE RANGED FROM 27 TO 65 YEARS. TARGET CELLS WERE COLLECTED IN ONE PROCEDURE IN SIXTEEN PATIENTS, WHILE IN FOUR PATIENTS THEY WERE COLLECTED IN TWO PROCEDURES. THE MEAN CD34+ COLLECTION EFFICIENCY WAS (B)(4). THE MEDIAN NUMBER OF CD34+ CELLS AND PERCENTAGE OF CD34+ CELLS IN THE PRODUCTS WERE 5.52X10E6/KG (RANGE (B)(4)) AND (B)(4) (RANGE (B)(4)). A STRONG POSITIVE CORRELATION WAS FOUND BETWEEN THE NUMBER OF CD34+ CELLS IN PERIPHERAL BLOOD ON THE APHERESIS DAY AND THE AMOUNT OF CD34+ CELLS COLLECTED IN THE PRODUCTS ((B)(4)). A TOTAL OF (B)(4) OF PATIENTS COLLECTED THE AMOUNT OF =3X10E6/KG AND (B)(4) OF =5X10E6/KG CD34+ CELLS FOR A SINGLE TRANSPLANT. A DECREASE IN PLATELET COUNT, HEMOGLOBI

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

  MAUDE report 18951290 ↗
• MalfunctionFeb 8, 2024Adverse 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 "REAL-WORLD EXPERIENCE IN EXTRACORPOREAL PHOTOPHERESIS FOR ADULTS WITH GRAFT-VERSUS-HOST DISEASE". TRANSPLANT CELL THER #VOLUME# (2023): #PAGES#" BY ASENSI CANTÓ, P.,SANZ CABALLER, J.,SOPEÑA PELL-ILDERTON, C.,SOLÍS RUIZ, J.,LLORET MADRID, P.,MONTANER VILLALBA, M.,FACAL MALVAR, A.,CHORÃO, P.,GUERREIRO, M.,BALAGUER ROSELLÓ, A.,MONTORO GÓMEZ, J.,SANTIAGO BALSERA, M.,SOLVES ALCAÍNA, P.,SANZ ALONSO, M. A.,DE LA RUBIA COMOS, J.,GÓMEZ-SEGUÍ, I.. BACTERIAL ISOLATES FOUND IN THE APHERESIS PRODUCT INCLUDED MICROCOCCUS LUTEUS, KLEBSIELLA PNEUMONIAE, AND ESCHERICHIA COLI. IMMEDIATE ANTIBIOTICS ADMINISTRATION WAS INITIATED ON DETECTION OF K. PNEUMONIAE AND E. COLI, PREVENTING THE PROGRESSION TO CLINICAL INFECTION. BECAUSE M. LUTEUS WAS CONSIDERED A CONTAMINATION OF CULTURES, NO SPECIFIC ACTION WAS TAKEN. ALL 3 CASES WERE THOROUGHLY INVESTIGATED, AND THE PRESENCE OF BACTEREMIA WAS CONSIDERED AN EARLY RECOGNITION OF SILENT BACTEREMIA RATHER THAN A MANIPULATION-TRANSMITTED INFECTION. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE BECAUSE THERE ARE MANY MONTHS BETWEEN COLLECTION OF DATA, TO PEER REVIEW, TO FINAL PUBLICATION. THE COLLECTION SET IS NOT AVAILABLE FOR RE

  Patient problems: Bacterial Infection

  MAUDE report 18670518 ↗
• MalfunctionDec 28, 2022Adverse 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 A CASE OF POSITIVE CULTURES IN AN APHERESIS PRODUCT. THE PACKAGING WAS INTACT PRIOR TO USAGE. PATIENT INFORMATION AND OUTCOME ARE NOT AVAILABLE AT THIS TIME. THE APHERESIS SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

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

  MAUDE report 16062014 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PRESENTATION ABSTRACT, 'VALIDATION OF COLLECTION AND CRYOPRESERVATION OF AUTOLOGOUS MONONUCLEAR CELLS INTENDED FOR CAR-T CELLS PRODUCTION' DISCUSSES A STUDY OF THE VALIDATION OF COLLECTION AND PRESERVATION OF MONONUCLEAR CELLS (MNCS) TO BE USED FOR CAR-T CELL PRODUCTION. THE STUDY REVIEWED CASES BETWEEN DEC 2019 AND NOV 2021. THE PATIENTS INVOLVED INCLUDED 2 CHILDREN AND 2 YOUNG ADULTS WITH ACUTE LYMPHOCYTIC LEUKEMIA (ALL) AND 23 ADULTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL). MEDIAN AGE WAS 57 YEARS. MEDIAN WEIGHT WAS 75KG. IN TWO PROCEDURES HEPARIN WAS ADDED TO RESOLVE CLOTTING. IN ONE PATIENT MILD SYMPTOMS OF HYPOCALCAEMIA WERE OBSERVED. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. THE APHERESIS SETS ARE NOT AVAILABLE FOR RETURN FOR EVALUATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16053738 ↗
• MalfunctionJul 21, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem

  THE CUSTOMER REPORTED THAT DURING AN APHERESIS TREATMENT ON A 16KG CHILD, THE OPERATOR DID NOT CLOSE THE SALINE LINE CLAMP. THE 1000ML BAG WAS EMPTIED. THE CUSTOMER REPORTED THAT NO MEDICAL INTERVENTION WAS NECESSARY. PATIENT ID, AGE, AND GENDER ARE NOT AVAILABLE AT THIS TIME. TERUMO BCT IS AWAITING THE RETURN OF THE DEVICE.

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

  MAUDE report 15079502 ↗
• InjuryFeb 10, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE PATIENT HAD A REACTION TO ANTICOAGULANT WITH HYPOCALCEMIA AND TETANY. 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: Hypersensitivity/Allergic reaction

  MAUDE report 13507321 ↗
• MalfunctionJan 11, 2022Misassembled; Misassembled; Component Missing

  THE CUSTOMER REPORTED THAT AFTER THE APHERESIS PROCEDURE, THEY SAW THAT THE RUBBER ON THE APHERESIS BAG WAS NOT PRESENT ON THE BUMP. THE RUBBER WAS NOT PRESENT DURING THE ENTIRE PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE RECIPIENT. THE TISSUE BANK SHOWED THAT DURING BACTALERT HEMOCULTURES AEROBIC AND ANAEROBIC TESTING GRAM POSITIVE COCCI WERE PRESENT IN THE PERIPHERAL BLOOD STEM CELLS COLLECTED. STAPHYLOCOCCUS EPIDERMIDIS (AEROBIC CULTURE) ¿ STAPHYLOCOCCUS CAPITIS (ANAEROBIC CULTURE) PATIENT IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLES SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13227134 ↗
• InjuryJan 3, 2022Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A DONOR HAD SEVERE TETANY WITH DYSPNOEA DURING A SPECTRA OPTIA PROCEDURE. PER THE CUSTOMER THE PATIENT IS RECOVERED. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Cramp(s) /Muscle Spasm(s); Dyspnea

  MAUDE report 13142493 ↗
• MalfunctionOct 18, 2021Use of Device Problem; Computer Software Problem; Use of Device Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE SPECTRA OPTIA DEVICE WAS NOT TRANSFERRING THE RUN DATA INFO OVER AND THERE IS BLOOD CLOTTING. PER THE CUSTOMER THE CLOTS WERE IN THE COLLECTION BAG. CLOTTING WAS NOTICED ABOUT 3:3 HRS INTO THE PROCEDURE. RETURN PRESSURE ALARM. THE CUSTOMER SWITCHED LINES AND HAD THE ALARM AGAIN. THE CUSTOMER THEN PULLED BLOOD CLOTS OUT OF THE IJ OF THE CATHETER AND THE TUBING. PER THE CUSTOMER IT WAS AT THAT POINT THE PATIENT WAS DISCONNECTED. THE CUSTOMER DID NOT NOTICE IF THE FRANGIBLE WAS BROKEN AT THE TIME THE DISPOSABLE SET WAS UNLOADED. THE CUSTOMER LOOKED AT THE SAVED BAG OF ACDA AND THOUGHT IT LOOKED MORE FULL THAN ORIGINALLY STATED WHEN COMPARING IT TO AN UNOPENED BAG. PER THE CUSTOMER, THE FRANGIBLE PROBABLY WASN'T BROKEN. TERUMO BCT CUSTOMER SUPPORT DISCUSSED WITH THE POSSIBILITY THAT THE FRANGIBLE WASN'T BROKEN AND WHY IT WOULD NOT HAVE BEEN NOTICED IF THERE WAS STILL FLUID IN THE CHAMBER. THE CUSTOMER UNDERSTOOD THE REASONING AND AGREED THAT WAS MORE THAN LIKELY THE PROBLEM. PER THE CUSTOMER THE PATIENT LEFT WITHOUT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12651463 ↗
• MalfunctionMay 27, 2021Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  PER THE CUSTOMER, THERE WAS NO MICROBUBBLES PRESENT IN THE BLOOD WARMER TUBING COILED AROUND THE HEATER EXCHANGER. ONLY AIR WAS ONLY OBSERVED IN THE TUBING GOING TO THE PATIENT'S FEMORAL VASCATH, APPROXIMATELY 30CM. THE CUSTOMER STATED THAT THE RETURN LUER CONNECTION WAS SECURE. THE OPERATOR FLUSHED THE PATIENT'S ARTERIAL LUMEN USING A PREFILLED SALINE SYRINGE AND NOTED THE CONNECTION TO BE SECURE. THERE WAS NO OTHER ACCESSORY OR STOP COCK ATTACHED TO THE DISPOSABLE TUBING SET. THERE WAS NO MENTION OF A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894903 ↗
• MalfunctionMar 15, 2021Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER DECLINED TO PROVIDE THE PATIENT IDENTIFIER.

  Patient problems: Bacterial Infection

  MAUDE report 11485299 ↗
• MalfunctionMar 15, 2021Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER.

  Patient problems: Bacterial Infection

  MAUDE report 11484172 ↗
• MalfunctionMar 15, 2021Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER.

  Patient problems: Bacterial Infection; Insufficient Information

  MAUDE report 11484130 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE ARTICLE, "FREQUENT PLATELET DONATION IS ASSOCIATED WITH LYMPHOPENIA AND RISK OF INFECTIONS: A NATIONWIDE COHORT STUDY", A STUDY FOUND THAT 30% OF FREQUENT PLATELTPHERESIS DONORS HAD SEVERE T-CELL LYMPHOPENIA (<200X10^6 CELLLS/L), WHICH PERSISTED FOR AT LEAST A YEAR AFTER CEASING DONATIONS. TONE SITE FROM THE STUDY USED SPECTRA OPTIA WITH A LEUKOREDUCTION SYSTEM (LRS) CHAMBER. ACCORDING TO THE ARTICLE, "THE CLINICAL SIGNIFICANCE OF PLATELETPHERESIS ASSOCIATED LYMPHOPENIA IS UNCLEAR, AND THERE ARE NO STUDIES ADDRESSING LONG-TERM HEALTH EFFECTS OF REPEATED LYMPHOCYTE DEPLETION IN PLATELETPHERESIS DONORS." FOR COMMON BACTERIAL INFECTIONS, THERE WAS AN INCREASED RISK FOR INFECTIONS ONLY AMONG MOST FREQUENT DONORS WITH MORE 50 DONATIONS (HR, 2.5; 95% CI, 1.2-4.9). EVENTS WERE RARE, WITH ONLY FIVE EVENTS (4.6/1000 PERSON-YEARS) FOR THE MOST FREQUENT DONORS WITH MORE THAN 90% LRS DONATIONS. FOR IMMUNOSUPPRESSION-RELATED INFECTIONS, NO STATISTICAL DIFFERENCE COULD BE FOUND; AMONG MOST FREQUENT DONORS. PATIENT DETAILS, INCLUDING PATIENT INFORMATION AND OUTCOMES ARE NOT AVAILABLE. THE ARTICLE WAS BASED ON A PAST STUDY AND DID NOT INCLUDE PATIENT DETAILS, THEREFORE THIS RE

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 11057358 ↗
• MalfunctionAug 23, 2019Excess Flow or Over-Infusion; Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem

  PER THE CUSTOMER, AFTER TAKING THE DIURETIC, THE PATIENT'S VITAL SIGNS RETURNED TO NORMAL.

  Patient problems: Complaint, Ill-Defined; No Known Impact Or Consequence To Patient

  MAUDE report 8926156 ↗
• MalfunctionMay 7, 2019Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT WHILE PERFORMING A MONONUCLEAR CELL (MNC) COLLECTION PROCEDURE ONA SPECTRA OPTIA DEVICE, THE PATIENT DEVELOPED HYPOTENSION. DURING VOLUME PROCESS AT 1.0, THE PATIENTS BLOOD PRESSURE (BP) DECREASED FROM 192/67 TO 99/55, THE RN DECREASED THE ANTICOAGULANT (AC) INFUSION RATE FROM 0.9 ML/MIN TO 0.7 ML/MIN AND PAUSED THE PROCEDURE. THE PROCEDURE WAS RESTARTED AFTER THE PATIENT WAS STABILIZED. APPROXIMATELY 9 MINUTES AFTER RESTARTING THE COLLECTION, THE PATIENT'S BP DROPPED AGAIN FROM 107/51 TO 91/52 AND THEN TO 85/43. THE OPERATOR PERFORMED RINSEBACK, RESULTING IN THE PATIENTS BP INCREASING TO 140/62. THE CUSTOMER REPORTED THAT THE PATIENT RECEIVED JUICE AND (B)(6) AND THERE WERE NO ADDITIONAL BOLUSES GIVEN TO THE PATIENT FOR THIS EVENT. PER THE CUSTOMER AFTER PERFORMING RINSEBACK, THE PATIENT IS REPORTED IN 'STABLE' CONDITION AND WENT HOME. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT IDENTIFIER (ID). TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION.

  Patient problems: Low Blood Pressure/ Hypotension; Reaction

  MAUDE report 8587208 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Pressure Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL UNPLANNED PRESCRIPTION MEDICATIONS WERE REQUIRED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8578039 ↗
• InjuryMar 1, 2019Use of Device Problem; No Flow; Therapeutic or Diagnostic Output Failure; Use of Device Problem

  DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. DONOR GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF).

  Patient problems: No Known Impact Or Consequence To Patient; Reaction

  MAUDE report 8382004 ↗
• MalfunctionNov 19, 2018Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT APPROXIMATELY 24 MINUTES INTO A MONO NUCLEAR CELL (MNC)COLLECTION PROCEDURE ON AN ALLOGENIC DONOR, THEY RECEIVED A 'CENTRIFUGE PRESSURE EXCEEDED LIMIT' ALARM. UPON INSPECTION, THE OPERATOR NOTICED AIR BUBBLES IN THE ACCESS LINE. PER CUSTOMER, THE OPERATOR PAUSED THE PROCEDURE AND CHECKED THE LOADING OF THE SET. NO ISSUES WERE FOUND AND THE PROCEDURE WAS CONTINUED. THE OPERATOR STATED THAT BUBBLES IN THE ACCESS LINE CLEARED AND THEY CLAMPED THE ACCESS LINE. THE RED ROLLER CLAMP WAS FOUND CLOSED AND THE ACCESS LINE WAS FOUND TO BE WORKING WELL. THE ACCESS LINE WAS DETACHED AND FLUSHED WITH SALINE AND NOT CLOTTING WAS FOUND. WHILE CHECKING THE RETURN LINE OPERATOR NOTICED THAT THE INLET SALINE ROLLER CLAMP WAS NOT CLOSED AND THE SALINE BAG WAS EMPTY. THE OPERATOR CLOSED THE SALINE ROLLER CLAMP AND REPLACED THE SALINE BAG AND CONTINUED WITH THE PROCEDURE. AFTER COLLECTING THE 1ST CHAMBER, THE OPERATOR PAUSED THE PROCEDURE AND DISCONNECTED THE PATIENT. THE INLET ACCESS AND RETURN LINES WERE THEN FLUSHED WITH SALINE TO ENSURE THAT THERE WAS NO AIR IN THE SALINE LINE. THE CUSTOMER CONTINUED THE PROCEDURE WITHOUT ANY FURTHER ISSUES. DUE TO EU PERSONAL DATA PROTEC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8085724 ↗