BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3201177 · Received July 2, 2013

    Report

    Report Number
    1722028-2013-01273
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE RUN DATA FILE WAS ANALYZED FOR THIS EVENT. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND A CONCLUSIVE CAUSE FOR THE HIGHER-THAN-EXPECTED WBC CONTENT REPORTED FOR THIS COLLECTION. THE SIGNALS IN THE RUN DATA FILE INDICATE IT IS POSSIBLE, THOUGH NOT CONCLUSIVE, THAT THE PLASMA LINE MAY HAVE BEEN PARTIALLY OCCLUDED NEAR THE END OF THE PROCEDURE. IF THE PLASMA LINE DOES NOT CONTRIBUTE PROPERLY TO THE PLATELET PUMP, IT COULD CAUSE THE FLOW THROUGH THE LRS CHAMBER TO BE HIGHER THAN THE SYSTEM EXPECTS, POSSIBLY ALLOWING SOME WBCS TO ESCAPE. IMPROPER LOADING OF THE DISPOSABLE KIT MAY CONTRIBUTE TO THE ABOVE. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    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. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. 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. AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF ELEVATED RWBCS RELATED TO PLASMA LINE OCCLUSIONS.

    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. DONOR UNIT #: (B)(6) THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. 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
    301526 TRIMA ACCEL TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET GKT TERUMO BCT 04V1220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other