BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 6190888 · Received December 20, 2016

    Report

    Report Number
    1722028-2016-00657
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 21, 2016
    Report Date
    December 20, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK150321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN PMA#, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. INVESTIGATION: 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. REVIEW OF THE RDF DID NOT SHOW A DEFINITIVE ROOT CAUSE FOR THE HIGHER THAN EXPECTED WBC COUNT OF THE PLATELET PRODUCT. SIGNALS SHOWED THAT PLATELETS EXITED THE CHAMBER IMMEDIATELY AFTER THE PLATELET VALVE OPENED AND REMAINED CONSISTENT DURING THE ENTIRE COLLECTION. BASED ON THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THIS LEUKOREDUCTION FAILURE MAY BE DONOR RELATED.

    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 EXPERIENCEDBY THE CUSTOMER INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO CORRECT INFORMATION IN DATE OF EVENT.

    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 BLOODCELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. (B)(6) THE PLATELET COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS PRODUCT IS NOT AVAILABLE WITHIN THE US, BUT THIS REPORT IS BEING FILED DUE TO A ALLEGED FAILURE THAT COULD OCCUR ON A SIMILARLY MARKETED DEVICE PLATFORM CLEARED FOR USE BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842261 TRIMA ACCEL TRIMA ACCEL LRS, PLT + AUTO PAS, PLS SET GKT TERUMO BCT 05Z9104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other