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Trima Accel® 80440Recalls & reported problems

Terumo Bct, Inc. · Disposable Tubing Sets, Platelet + Sampler, Plasma, RBC Set · Class 2

Quick summary

This is a Trima Accel blood cell separator tubing set. Reports mostly describe elevated white blood cell levels in platelet or red cell collections, treated as device malfunctions. There are 93 reports, including 1 death, 8 injuries, and 84 malfunctions. No recalls name this device identifier.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
93
Deaths reported
1
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 05020583804401), received between Jul 13, 2018 and Dec 21, 2022 — classified as 1 death, 8 injuries, 84 malfunctions.

The most frequently reported specific device problem is “High Test Results” (22 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

Device problems

  • Adverse Event Without Identified Device or Use Problem85
  • High Test Results22
  • High Readings18
  • Use of Device Problem7
  • Microbial Contamination of Device5
  • Incorrect, Inadequate or Imprecise Result or Readings4
  • Contamination of Device Ingredient or Reagent3
  • Device Displays Incorrect Message3

Patient problems

  • No Patient Involvement63
  • No Clinical Signs, Symptoms or Conditions17
  • No Known Impact Or Consequence To Patient11
  • Reaction2
  • Death1
  • Discomfort1
  • Dyspnea1
  • Infiltration into Tissue1

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 21, 2022Adverse 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 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 16026896 ↗
  • MalfunctionAug 22, 2022Adverse 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. DONOR UNIT #: (B)(6). 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 15265837 ↗
  • MalfunctionDec 10, 2021High 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 RED BLOOD CELL (RBC) 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. 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 12975860 ↗
  • MalfunctionJun 23, 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 RED BLOOD CELL (RBC) 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 ID: (B)(6), 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 12050816 ↗
  • MalfunctionFeb 26, 2021Use of Device Problem; Use of Device Problem; High Readings

    KW 03-30-2021. 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 11385722 ↗
  • MalfunctionFeb 17, 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. 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 11338045 ↗
  • MalfunctionFeb 1, 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. 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 11259087 ↗
  • MalfunctionFeb 1, 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 #: (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 11258581 ↗
  • MalfunctionJan 27, 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. 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 11237380 ↗
  • MalfunctionJan 27, 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. 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 11237223 ↗
  • MalfunctionJan 14, 2021High 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 #: W091020456151 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 11170376 ↗
  • MalfunctionDec 28, 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. THERE IS NO PATIENT INVOLVED FOR THIS EVENT. SEX AND WEIGHT ARE NOT APPLICABLE FOR THIS EVENT AND CAN NOT BE REMOVED DUE TO A SYSTEM LIMITATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11078127 ↗
  • MalfunctionDec 28, 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. NO PATIENT IS INVOLVED, PATIENT SEX AND WEIGHT ARE NOT APPLICABLE FOR THIS EVENT AND CAN NOT BE REMOVED DUE TO A SYSTEM LIMITATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11077916 ↗
  • MalfunctionSep 16, 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)(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; No Patient Involvement

    MAUDE report 10540820 ↗
  • MalfunctionSep 9, 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 10508027 ↗
  • MalfunctionAug 10, 2020High 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) THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Patient problems: No Patient Involvement

    MAUDE report 10385297 ↗
  • MalfunctionJul 24, 2020High 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. DONOR UNIT #: (B)(6) 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. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Patient problems: No Patient Involvement

    MAUDE report 10320560 ↗
  • MalfunctionJul 14, 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; No Patient Involvement

    MAUDE report 10271335 ↗
  • MalfunctionJul 14, 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; No Patient Involvement

    MAUDE report 10271301 ↗
  • MalfunctionJun 9, 2020Use of Device Problem; Use of Device Problem; Device Displays Incorrect Message

    THE CUSTOMER REPORTED A PRESSURE TEST ERROR ALARM DURING SET UP OF THE DISPOSABLE SET FOR A PLATELET COLLECTION ON A TRIMA DEVICE. THERE WAS NOT A DONOR CONNECTED AT THE TIME OF SET TEST, THEREFORE, PATIENT INFORMATION IS NOT REASONABLY KNOWN.

    Patient problems: No Patient Involvement

    MAUDE report 10135622 ↗
  • InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem

    THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION AND ADDITIONAL PROCEDURAL DETAILS FOR THIS EVENT.

    Patient problems: Injury

    MAUDE report 10101482 ↗
  • MalfunctionApr 9, 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. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THE WBC COUNT IS NOT AVAILABLE, AT THIS TIME.

    Patient problems: No Patient Involvement

    MAUDE report 9946532 ↗
  • MalfunctionApr 9, 2020High 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. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THE WBC COUNT IS NOT AVAILABLE, AT THIS TIME.

    Patient problems: No Patient Involvement

    MAUDE report 9946525 ↗
  • MalfunctionApr 9, 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. THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THE WBC COUNT IS NOT AVAILABLE, AT THIS TIME.

    Patient problems: No Patient Involvement

    MAUDE report 9946403 ↗
  • MalfunctionApr 9, 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 #: W0354 20 018871 00 THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Patient problems: No Patient Involvement

    MAUDE report 9943824 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.