BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL ENHANCED PLT, PLS, RBC SET

    MDR report key: 2419949 · Received December 1, 2011

    Report

    Report Number
    1722028-2011-00460
    Event Type
    Malfunction
    Date Received
    December 1, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 18, 2011
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    GKT
    PMA / PMN Number
    BK110009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS YEAR. SIGNALS IN THE RDF INDICATE IT IS POSSIBLE, THOUGH NOT CONCLUSIVE, THAT THE PLASMA LINE MAY HAVE BEEN PARTIALLY OCCLUDED DURING A PORTION OF THE PROCEDURE. IF THE PLASMA LINE DOES NOT CONTRIBUTE PROPERLY TO THE PLATELET PUMP IT COULD CAUSE THE FLOW THROUGH THE LRS CHAMBER TO BE HIGHER THAN THE SYSTEM EXPECTS, POSSIBLY ALLOWING SOME WBCS TO ESCAPE. ORIENTATION OF THE HEX IN THE HEX HOLDER MAY CONTRIBUTE TO THIS. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE EVALUATED WHITE BLOOD CELL (WBC) CONTENT IN THE PLATELET PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PT INFO IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(4). 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
    1 TRIMA ACCEL ENHANCED PLT, PLS, RBC SET AUTOMATED BLOOD CELL SEPARATOR GKT GAMBRO BCT, INC. 09T1204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other