BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 6132727 · Received November 29, 2016

    Report

    Report Number
    1722028-2016-00616
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 29, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK150321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 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. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. 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 WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #:(B)(6). THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783352 TRIMA ACCEL TRIMA ACCEL PLATELET + SAMPLER, PLASMA RBC SET GKT TERUMO BCT 09Z4213

    Patients

    Seq Age Sex Outcome Treatment
    1 00000 Other