BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 2871359 · Received December 13, 2012

    Report

    Report Number
    1722028-2012-00915
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    August 26, 2012
    Report Date
    November 21, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED LEUKOREDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME. WBC CONTAMINATION OF PLATELET PRODUCTS CAN POTENTIALLY BE DUE TO: THIS SITE'S STATISTICAL DISTRIBUTION, LATE OR MAJOR CHANGES, ESPECIALLY IN HEMATOCRIT, CAN CONTRIBUTE TO AN ELEVATED WBC COUNT, DONOR PHYSIOLOGY, SAMPLING, CALCULATION, OR OTHER PROCESS ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE DOUBLE PLATELET PRODUCT. THE MACHINE GAVE THE MESSAGE TO 'VERIFY 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. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A (B)(4) REPORT WITH THEIR REGULATORY BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC, AUTOPAS SET GKT TERUMO BCT 10T1213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other