Trima Accel® 80400Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 05020583804005), received between Jul 13, 2018 and Aug 23, 2024 — classified as 8 injuries, 101 malfunctions.

The most frequently reported specific device problem is “High Test Results” (23 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 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 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 "PLATELETPHERESIS IN THE ERA OF AUTOMATION: OPTIMIZING DONOR SAFETY AND PRODUCT QUALITY USING MODERN APHERESIS INSTRUMENTS". BY DAS, S. S., SEN, S., ZAMAN, R. U., BISWAS, R. N. ABSTRACT: THE INCREASES IN MAJOR SURGERIES, TRANSPLANTATIONS AND SPECIALITY CLINICS HAVE SIGNIFICANTLY INCREASED THE UTILIZATION OF PLATELET CONCENTRATES INCLUDING SINGLE DONOR PLATELETS (SDP). THE ADVANTAGES OF SDP OR APHERESIS PLATELET HAVE BEEN DISCUSSED ELABORATELY BY PREVIOUS AUTHORS AS COMPARED TO RANDOM DONOR PLATELETS. HERE WE SHARE OUR EXPERIENCES OF PLATELETPHERESIS PROCEDURES USING THE MODERN APHERESIS MACHINES WITH REGARDS TO PRODUCT QUALITY AND DONOR SAFETY. THIS STUDY INCLUDED 3016 PROCEDURES OF PLATELETPHERESIS (1397 ON AMICUS AND 1619 ON TRIMA ACCEL CELL SEPARATORS) ON ELIGIBLE DONORS USING RECOMMENDED APHERESIS KITS. A TARGET YIELD OF 3 9 1011 WAS SET AS THE END POINT OF EACH PROCEDURE. DONOR DETAILS, PROCEDURE DETAILS AND DONOR ADVERSE REACTIONS IF ANY WERE DOCUMENTED. STATISTICAL ANALYSIS WAS DONE USING THE SPSS STATISTICAL PACKAGE (VERSION 13, USA). OF THE TOTAL 6276 DONORS SCREENED 2049 (32.6%) WERE DEFERRED DUE TO VARIOUS REASONS. OUT OF REMAINING 4227 ELIGIBLE DONOR

  Patient problems: Anxiety; Loss of consciousness; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 20055959 ↗
• InjuryAug 23, 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, "A COMPARATIVE STUDY OF FIVE PLATELETPHERESIS MACHINES IN A TERTIARY CARE CENTER OF INDIA: AMICORE VS COM.TEC VS HAEMONETICS MCS+ VS SPECTRA OPTIA VS TRIMA ACCEL", BYARCOT, P. J., KUMAR, K., COSHIC, P., ANDRIYAS, V., & MEHTA, V., SINGLE DONOR APHERESIS PLATELETS ARE SUPERIOR IN QUALITY, BUT THEIR USAGE IS LIMITED IN A DEVELOPING COUNTRY DUE TO COST AND TIME CONSTRAINTS. HENCE THE PRODUCT OBTAINED MUST EXCEED IN TERMS OF YIELD, DONOR SAFETY AND TECHNICAL CONVENIENCE. PREVIOUS LITERATURE AVAILABLE ON CELL SEPARATORS IS ON OLDER VERSIONS. PROSPECTIVE COMPARISON OF 5 LATEST CELL SEPARATORS (AMICORE, COM. TEC, HAEMONETICS MCS+, SPECTRAOPTIA AND TRIMAACCEL) FOR PRODUCT YIELD, PERFORMANCE VARIABLES AND DONOR ADVERSE EFFECTS. FROM OCTOBER 2019 - MARCH 2020,1108 DONORS WERE RANDOMLY ALLOTTED TO A CELL SEPARATOR. POST-DONATION SAMPLE WAS TAKEN FROM THE DONOR 15-20 MINUTES AFTER PROCEDURE COMPLETION. THE PLATELET YIELD FROM THE PRODUCT COLLECTED WAS MEASURED TWICE (DAY 0 AND DAY 1). DONOR DEMOGRAPHY, PRE-AND POST-PROCEDURAL DONOR PERIPHERAL BLOOD VALUES, PERFORMANCE AND PRODUCT VARIABLES WERE STATISTICALLY ANALYZED. AMICORE HAD AN OPTIMAL COLLECTION EFFICACY (44.6%) AND C

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 20050355 ↗
• MalfunctionSep 1, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  PER JOURNAL ARTICLE "POSTTRANSFUSION SEPSIS ATTRIBUTABLE TO BACTERIAL CONTAMINATION IN PLATELET COLLECTION SET MANUFACTURING FACILITY, UNITED STATES" BY IAN KRACALIK, ET ALL. DURING (B)(6) 2022, WE REVIEWED TRANSFUSION-TRANSMITTED SEPSIS CASES IN THE UNITED STATES ATTRIBUTABLE TO POLYMICROBIAL CONTAMINATED APHERESIS PLATELET COMPONENTS, INCLUDING ACINETOBACTER CALCOACETICUS BAUMANNII COMPLEX OR STAPHYLOCOCCUS SAPROPHYTICUS ISOLATED FROM PATIENTS AND COMPONENTS. TRANSFUSED PLATELET COMPONENTS UNDERWENT BACTERIAL RISK CONTROL STRATEGIES (PRIMARY CULTURE, PATHOGEN REDUCTION OR PRIMARY CULTURE, AND SECONDARY RAPID TEST) BEFORE TRANSFUSION. ENVIRONMENTAL SAMPLES WERE COLLECTED FROM A PLATELET COLLECTION SET MANUFACTURING FACILITY. SEVEN SEPSIS CASES FROM 6 PLATELET DONATIONS FROM 6 DIFFERENT DONORS WERE IDENTIFIED IN PATIENTS FROM 6 STATES; 3 PATIENTS DIED. CULTURES IDENTIFIED ACINETOBACTER CALCOACETICUS BAUMANNII COMPLEX IN 6 PATIENTS AND 6 TRANSFUSED PLATELETS, S. SAPROPHYTICUS IN 4 PATIENTS AND 4 TRANSFUSED PLATELETS. WHOLE-GENOME SEQUENCING SHOWED ENVIRONMENTAL ISOLATES FROM THE MANUFACTURER WERE CLOSELY RELATED GENETICALLY TO PATIENT AND PLATELET ISOLATES, INDICATING THE MANUFACTUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671711 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, 'THE IMPACT OF DELAYED AND IMMEDIATE ADVERSE EVENTS ON THE INTENTION OF FUTURE DONATIONS IN WHOLE BLOOD AND PLATELETPHERESIS DONORS', DISCUSSES A PROSPECTIVE OBSERVATIONAL STUDY THAT WAS DONE AT A TERTIARY CARE HOSPITAL-BASED BLOOD TRANSFUSION SERVICE. THE STUDY WAS CONDUCTED OVER 11 MONTHS FROM OCTOBER 2018 TO AUGUST 2019. ALL PLATELETPHERESIS PROCEDURES WERE DONE ON EITHER HAEMONETICS MCS+ ((B)(6)) OR TRIMA ACCEL (TERUMO BCT, (B)(4)). A TOTAL OF 531 PLATELETPHERESIS DONORS WERE INCLUDED IN THE STUDY. THE MEDIAN AGE, WEIGHT, HEMOGLOBIN, AND PLATELET COUNTS OF THE PLATELETPHERESIS DONORS WERE 29 YEARS, 75 KG, 15.3 MG/DL, AND 233/L RESPECTIVELY. THE FOLLOWING TABLE SUMMARIZES THE NUMBER OF ADVERSE EVENTS FOR PLATELETPHERESIS DONORS. THIS LIST INCLUDES USE OF BOTH THE HAEMONETICS MCS+ OR TRIMA ACCEL, THE DATA WAS NOT SEGREGATED BY THE AUTHORS. ADVERSE EVENT NUMBER (PERCENT) BRUISE 39 (7.3) SORE ARM 19 (3.6) HEMATOMA 10 (1.9) ALLERGIC REACTION 11 (2.1) DELAYED BLEEDING 12 (2.3) PARASTHESIAE 6 (1.1) FATIGUE/WEAKNESS 12 (2.3) VASO-VAGAL REACTION 3 (0.6) MUSCULAR SPASM 2 (0.4) THE ARTICLE DID NOT PROVIDE FURTHER DETAILS ABOUT THE ADVERSE DONOR EVENTS, INCLUDING WHETHER OR NO

  Patient problems: Bruise/Contusion; Cramp(s) /Muscle Spasm(s); Fatigue; Hematoma; Hypersensitivity/Allergic reaction

  MAUDE report 14174227 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem

  IN THE ARTICLE, 'COMPARISON OF QUALITY AND EFFICACY OF APHERESIS PLATELETS STORED IN PLATELET ADDITIVE SOLUTION VIS A VIS PLASMA', AT A TERTIARY CARE ONCOLOGY CENTER, A TOTAL OF 520 PLATELETPHERESIS PROCEDURES WERE PERFORMED BETWEEN DECEMBER 2017 AND DECEMBER 2018, OF WHICH 73 WERE INCLUDED IN A STUDY DONE TO COMPARE THE QUALITY AND EFFICACY OF PLATELET ADDITIVE SOLUTIONS (PAS)-STORED SINGLE DONOR PLATELET (SDPS) AND PLASMA STORED SDPS. OF THE 73 SDP PLATELET CONCENTRATES (PCS), 42 WERE STORED IN PAS (STUDY GROUP) AND 31 IN DONOR PLASMA (CONTROL GROUP). IN THE STUDY GROUP 6 APHERESIS PROCEDURES WERE PERFORMED IN TRIMA ACCEL (TERUMO BCT, (B)(4)). IN THE CONTROL GROUP 7 PROCEDURES WERE PERFORMED IN TRIMA . THE PC RECIPIENTS INCLUDED PATIENTS OF ALL AGE GROUPS (RANGE: 2¿64 YEARS) WITH HAEMATOLOGICAL MALIGNANCY, UNDERGOING CHEMOTHERAPY OR STEM CELL TRANSPLANTATION. THERE WAS 1 ALLERGIC REACTION IN THE STUDY ARM FROM 81 TRANSFUSIONS AND 3 ALLERGIC REACTIONS IN THE CONTROL ARM FROM 61 TRANSFUSIONS. THE ALLERGIC REACTIONS WERE SEVERE AND ACCOMPANIED WITH HYPOTENSION IN 2 OF THE CONTROL ARM CASES, THE OTHER 2 CASES WERE MILD. THIS ARTICLE DID NOT PROVIDE DETAILS REGARDING THE ALLERGIC REAC

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 14112003 ↗
• MalfunctionMar 29, 2022Adverse Event Without Identified Device or Use Problem; Contamination of Device Ingredient or Reagent; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. DONOR UNIT #: (B)(4) THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13938864 ↗
• MalfunctionMar 23, 2022Contamination of Device Ingredient or Reagent; No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLASMA PRODUCT. NO ALARMS DISPLAYED DURING THE PROCEDURE. CUSTOMER REPORTED THAT THERE WAS BLOOD IN THE PLASMA BAG. THE DONOR BLOOD WAS VERY LIPEMIC AND THE PROCEDURE WAS STOPPED BY THE CUSTOMER DUE TO RBC SPILLOVER. WBC COUNT IS NOT AVAILABLE AT THIS TIME. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861345 ↗
• MalfunctionMar 21, 2022Contamination of Device Ingredient or Reagent; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. WBC COUNT IS NOT AVAILABLE AT THIS TIME. THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839965 ↗
• MalfunctionFeb 10, 2022Contamination of Device Ingredient or Reagent; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6) THE PLATELET COLLECTION IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13507385 ↗
• MalfunctionJun 30, 2021Adverse Event Without Identified Device or Use Problem; High Readings; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT, THEREFORE, NO PATIENT INFORMATION IS KNOWN. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093511 ↗
• MalfunctionJun 30, 2021No Apparent Adverse Event; High Readings; No Apparent Adverse Event

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT, THEREFORE, NO PATIENT INFORMATION IS KNOWN. WBC COUNT IS UNKNOWN AT THIS TIME. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093268 ↗
• MalfunctionFeb 19, 2021Adverse Event Without Identified Device or Use Problem; High Test Results; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: W036820174876 THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348625 ↗
• MalfunctionDec 22, 2020High Test Results; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6) THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057373 ↗
• MalfunctionDec 22, 2020High Test Results; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(4) THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056886 ↗
• MalfunctionDec 22, 2020High Test Results; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6) THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. DUE TO AN INTERNAL SYSTEM LIMITATION PATIENT SEX AND WEIGHT CAN NOT BE REMOVED. THERE IS NO PATIENT INFORMATION FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056878 ↗
• MalfunctionSep 22, 2020Device Displays Incorrect Message; Material Deformation; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY RECEIVED A PRESSURE TEST ERROR DURING SET TEST. THE CLAMPS WERE CHECKED. THE SYSTEM GAVE THE SAME ERROR AGAIN EVEN THOUGH THE WHITE CLAMPS WERE CLOSED. THE SAMPLE BAG WAS FOUND TO BE SWOLLEN. THE PROCEDURE WAS DISCONTINUED AND RESTARTED WITH A NEW SET. CUSTOMER DECLINED TO PROVIDE PATIENT (DONOR) IDENTIFIER DUE TO EU DATA PRIVACY LAWS. DONOR WAS NOT CONNECTED AT TIME OF INCIDENT. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER

  Patient problems: No Patient Involvement

  MAUDE report 10567338 ↗
• MalfunctionSep 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6). TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET.

  Patient problems: No Patient Involvement

  MAUDE report 10528254 ↗
• MalfunctionAug 31, 2020Device Ingredient or Reagent Problem; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6). THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

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

  MAUDE report 10471573 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem

  PURSUANT TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. INFORMATION ON THE EXTENT OF MEDICAL INTERVENTION REQUIRED, IF ANY, IS UNKNOWN.

  Patient problems: Reaction

  MAUDE report 10420155 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem

  THIS IS PROSPECTIVE STUDY THAT INCLUDED 1455 PLATELETPHERESIS PROCEDURES PERFORMED ON ELIGIBLE DONORS FROM JULY 2013 TO APRIL 2016. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

  Patient problems: Electrolyte Imbalance; Hematoma; Injury; Nausea; Numbness; Pain; Syncope; Syncope/Fainting; Tingling; Toxicity

  MAUDE report 10114504 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem

  IN ADDITION TO THE OTHER REPORTED ADVERSE EVENTS, THE ARTICLE ALSO MENTIONS THREE DONORS REPORTED HAVING A FEVER AFTER AP PROCEDURE. THE FEVER EPISODES WERE REPORTED BETWEEN DAY ONE AND DAY NINE OF DONATION. IN ALL THE CASES THE FEVER RECEDED WITHOUT ANY DIAGNOSIS AND COMPLICATIONS. DIARRHEA WAS REPORTED BY A SINGLE DONOR ON DAY FOUR OF DONATION. NONE OF THE DONORS REQUIRED HOSPITALIZATION. THIS WAS AN OBSERVATIONAL STUDY ON 531 DONORS BETWEEN OCTOBER 2018 TO JUNE 2019 TO PRIMARILY ANALYSE THE FREQUENCY AND TYPE OF DELAYED ADVERSE DONOR EVENTS. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

  Patient problems: Reaction

  MAUDE report 10106822 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER STATED THAT THEY ARE UNABLE TO PROVIDE DONOR (PATIENT) INFORMATION.

  Patient problems: Loss of consciousness

  MAUDE report 10097503 ↗
• MalfunctionMay 13, 2020Adverse Event Without Identified Device or Use Problem; Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem

  PER THE CUSTOMER, THE PRODUCT WAS DISCARDED. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

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

  MAUDE report 10051637 ↗
• MalfunctionApr 27, 2020Adverse Event Without Identified Device or Use Problem; High Test Results; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: W04702012060400 THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

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

  MAUDE report 10002432 ↗
• MalfunctionApr 21, 2020Adverse Event Without Identified Device or Use Problem; High Readings; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: W04702007192300A THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 9981063 ↗