BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 2970337 · Received February 20, 2013

    Report

    Report Number
    1722028-2013-00953
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 24, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE WAS INVESTIGATED FOR THE PROCEDURE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THIS LOT. THERE WERE NO ISSUES NOTED IN THE DHR THAT WOULD HAVE HAD AN IMPACT ON THE ELEVATED WBC COUNT THAT THE CUSTOMER EXPERIENCED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE OBSERVED LEUKOREDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND A CONCLUSIVE CAUSE FOR THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT REPORTED FOR THIS COLLECTION. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED AND THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE RULED OUT THAT THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT COULD BE DONOR-RELATED. IT ALSO CANNOT BE RULED OUT THAT A SAMPLING, CALCULATION, OR OTHER PROCESS ERROR COULD HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT.

    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
    74152 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET GKT TERUMO BCT 11U2106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other