BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3810444 · Received May 14, 2014

    Report

    Report Number
    1722028-2014-00173
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 18, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE RUN DATA FILE 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: A DEFINITIVE ROOT CAUSE FOR THE OBSERVED LEUKOREDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME. THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED AND THERE WAS NO INDICATION OF A CONCLUSIVE CAUSE FOR THE HIGHER-THAN-EXPECTED WBC CONTENT IN THE PLATELET PRODUCT REPORTED FOR THIS COLLECTION. THERE ARE SIGNALS IN THE RUN DATA FILE THAT ARE CONSISTENT WITH SOME POSSIBLE CLUMPING/AGGREGATION DURING THE COLLECTION. BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE RULED OUT THAT THIS CLUMPING/AGGREGATION COULD BE DONOR RELATED AND COULD HAVE AFFECTED THE SEPARATION OF CELLS IN THE LRS CHAMBER. IT ALSO CANNOT BE RULED OUT THAT A SAMPLING, CALCULATION, OR OTHER PROCESS ERROR COULD HAVE CONTRIBUTED TO THE ELEVATED 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
    288813 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET GKT TERUMO BCT 03W2124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other