BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 4251041 · Received November 14, 2014

    Report

    Report Number
    1722028-2014-00453
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 21, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. 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: THE RUN DATA FILE ANALYSIS DID NOT SHOW A WBC FLAG FOR THE PLATELET PRODUCT. HOWEVER, THE SIGNALS IN THE RUN DATA FILE INDICATE IT IS POSSIBLE, THOUGH NOT CONCLUSIVE, THAT THE PLASMA LINE MAY HAVE BEEN PARTIALLY OCCLUDED. WHEN THE PLASMA LINE IS OCCLUDED, THE PLASMA FLOW DESIGNED TO BE USED FOR THE LRS CHAMBER CLEARING TO SEND THE WBCS TO THE RESERVOIR IS HINDERED. THEREFORE, LITTLE IS GOING THROUGH THE LRS CHAMBER AND LITTLE TO NO CLEARING OF WBCS OCCURS. ORIENTATION OF THE HEX HOLDER MAY CONTRIBUTE TO THE ABOVE.

    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. 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
    737247 TRIMA ACCEL TRIMA ACCEL PLT, PLS, RBC, TLR SET GKT TERUMO BCT 03W2108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other