BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3872569 · Received June 13, 2014

    Report

    Report Number
    1722028-2014-00227
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 19, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THIS EVENT. THERE WERE NO EVENTS NOTED IN THE DHR THAT WOULD HAVE CONTRIBUTED TO THE ELEVATED WBC COUNT EXPERIENCED BY THE CUSTOMER. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE OBSERVED LEUKOREDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME. THE SIGNALS IN THE RDF INDICATE THAT THE HIGHER-THAN-EXPECTED WBC CONTENT IN THE PLATELET PRODUCT WAS LIKELY A RESULT OF AN ESCAPE OF WBCS FROM THE LRS CHAMBER DURING A PORTION OF THE PROCEDURE. THERE ARE NO EVENTS (ADJUSTMENTS,CHANGES IN PUMP SPEED, SUBSTATE CHANGES, ETC.) IN THE PROCEDURE THAT CORRESPONDS WITH THE ONSET OF THE OVERLOADING OF THE LRS CHAMBER. BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE RULED OUT THAT THE HIGHER-THAN-EXPECTED WBC CONTENT IN THE PLATELET PRODUCT COULD BE DONOR-RELATED. IT ALSO CANNOT BE RULED OUT THAT A SAMPLING, CALCULATION, OR OTHER PROCESS ERROR COULD HAVE CONTRIBUTED TO THE HIGHER-THAN-EXPECTED WBC CONTENT IN THE PLATELET PRODUCT.

    Description of Event or Problem · 1

    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 RWBC TESTING,THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT# (B)(6) THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION, THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350388 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET GKT TERUMO BCT 03W2213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other