BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3023077 · Received March 27, 2013

    Report

    Report Number
    1722028-2013-01062
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 5, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    K113480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THIS LOT. THERE WERE NOISSUES NOTED IN THE DHR THAT WOULD HAVE CONTRIBUTED 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 LEUKO REDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME. SIGNALS IN THE RUN DATA FILE DO NOT INDICATE A CONCLUSIVE CAUSE FOR THE GREATER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT REPORTED FOR THIS COLLECTION. NOUNUSUAL PROCESS VARIABLE WAS IDENTIFIED IN THE RUN DATA FILE. IT IS POSSIBLE THAT THIS FAILURE IS DRELATED.

    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. 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
    126059 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC SET GKT TERUMO BCT 07U1107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other