BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 8701200 · Received June 14, 2019

    Report

    Report Number
    1722028-2019-00146
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 14, 2019
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    UDI-DI
    05020583804005
    PMA / PMN Number
    BK180231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE 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: THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE HIGHER-THAN-EXPECTED WBC CONTENT IN THE PLATELET PRODUCT WAS POSSIBLY A RESULT OF AN ESCAPE OF WBC FROM THE LRS CHAMBER DURING A PORTION OF THE PROCEDURE. 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.

    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
    493186 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, RBC SET GKT TERUMO BCT 1810275151 05020583804005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other