BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 4791742 · Received May 22, 2015

    Report

    Report Number
    1722028-2015-00187
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 28, 2015
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK140180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION METHOD CODE: STERILIZATION PROCESS REVIEW INVESTIGATION: A TRIMA SET WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION CONFIRMED THE SET WAS ASSEMBLED CORRECTLY WITH NO KINKS, OCCLUSIONS OR MISSING CLAMPS. FLOW OF SOLUTION WAS OBSERVED THROUGH THE LRS CHAMBER. THERE WERE NO SIGNS OF DAMAGE TO THE CHANNEL AND THERE WERE NO WITNESS MARKS ON THE LOOP ASSEMBLY WHICH SUGGESTED THE SET WAS LOADED CORRECTLY. 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. ROOT CAUSE: THE INVESTIGATION OF THE RETURNED SET DID NOT LEAD TO A CONCLUSIVE ROOT CAUSE. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED LEUKOREDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME. POSSIBLE ROOT CAUSES WERE PROVIDED IN THE INITIAL REPORT FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. REVIEW OF THE RUN DATA FILE 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 6 MINUTES AFTER THE VALVE WAS OPENED AND THE CONCENTRATION WAS CONSISTENT DURING THE COLLECTION. IT IS POSSIBLE THAT AN ESCAPE OF WBCS FROM THE LRS CHAMBER DURING THE COLLECTION CONTRIBUTED TO THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT. BASED ON THE AVAILABLE INFORMATION, IT IS ALSO POSSIBLE THAT THIS LEUKO REDUCTION FAILURE MAY BE DONOR RELATED. 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 WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335557 TRIMA ACCEL TRIMA ACCEL PLATELET + SAMPLER, AUTOPAS, MLT PLS SET GKT TERUMO BCT 12W1207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other