BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3023633 · Received March 27, 2013

    Report

    Report Number
    1722028-2013-01065
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 5, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE (RDF) 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. ORIENTATION OF THE HEX IN THE HEX HOLDER MAY CONTRIBUTE TO THE ABOVE. IT IS ALSO POSSIBLE THAT THE HIGH NUMBER OF ACCESS ALERTS THAT OCCURRED THROUGHOUT THE PROCEDURE DISRUPTED THE STEADY-STATE OF THE SYSTEM AND CONTRIBUTED TO THE ELEVATED WBC CONTENT REPORTED FOR THIS COLLECTION. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. 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 OCCLUSION.

    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
    126759 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET GKT TERUMO BCT 02V2101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other