BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3840664 · Received May 30, 2014

    Report

    Report Number
    1722028-2014-00200
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 2, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. SIGNALS IN THE RUN DATA FILE DO NOT INDICATE A CONCLUSIVE CAUSE FOR THE GREATER THAN EXPECTED RWBC CONTENT IN THE PLATELET PRODUCT REPORTED FOR THIS COLLECTION.

    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 RESIDUAL WHITE BLOOD CELL (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
    319647 TRIMA ACCEL TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC, AUTO PAS S GKT TERUMO BCT 02W1223

    Patients

    Seq Age Sex Outcome Treatment
    1 Other