BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3964594 · Received July 29, 2014

    Report

    Report Number
    1722028-2014-00285
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 2, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 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. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. ROOT CAUSE: THE RUN DATA FILE ANALYSIS DID NOT SHOW A ROOT CAUSE FOR THE HIGHER-THAN-EXPECTED WBC CONTENT IN THE PLATELET PRODUCT REPORTED FOR THIS COLLECTION. BASED ON THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THIS LEUKOREDUCTION FAILURE MAY BE DONOR RELATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RETURNED FOR INVESTIGATION. THE PRODUCT BAGS HAD BEEN REMOVED FROM THE SET. THERE IS NO LR FILTER PRESENT ON THIS DISPOSABLE. UPON VISUAL INSPECTION NO MISASSEMBLIES WERE NOTED WITH THE SET. NO OCCLUSIONS WERE NOTED; FLUID MOVED EASILY WITHIN THE SET. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    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. 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
    441431 TRIMA ACCEL TRIMA ACCEL PLT, AUTOPAS, MULTI PLS SET GKT TERUMO BCT 04W1222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other