BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 2771031 · Received October 3, 2012

    Report

    Report Number
    1722028-2012-00782
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    July 3, 2012
    Report Date
    September 9, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK110068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED FOR THIS LOT. 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. POSSIBLE ROOT CAUSES WERE PROVIDED IN THE INITIAL REPORT FOR THIS EVENT. AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF ELEVATED WBC COUNTS RELATED TO PLASMA LINE OCCLUSIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE ANALYSIS OF THE RDF DID NOT FIND A CONCLUSIVE CAUSE FOR THE HIGHER THAN EXPECTED WBC CONTENT REPORTED FOR THIS COLLECTION. THE SIGNALS IN THE RUN DATA FILE INDICATE IT IS POSSIBLE, THOUGH NOT CONCLUSIVE, THAT THE PLASMA LINE MAY HAVE BEEN PARTIALLY OCCLUDED NEAR THE END 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 THE ABOVE. 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 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. 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
    1 TRIMA ACCEL TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET GKT TERUMO BCT 05U1126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other