BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3201250 · Received July 2, 2013

    Report

    Report Number
    1722028-2013-01272
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    June 7, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THIS LOT. THERE WERE NO ISSUES NOTED IN THE DHR THAT WOULD CONTRIBUTE TO THE ELEVATED WBC COUNT THAT THE CUSTOMER EXPERIENCED. THE RUN DATA FILE 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 RUN DATA FILE 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 THIS LEUKOREDUCTION FAILURE COULD BE DONOR-RELATED.

    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 WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. PATIENT WEIGHT WAS ENTERED INADVERTENTLY. DONOR UNIT #: (B)(6). THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. 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
    303136 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, RBC SET GKT TERUMO BCT 02V1106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other