BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3092301 · Received May 3, 2013

    Report

    Report Number
    1722028-2013-01181
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT COULD BE THE RESULT OF AN ESCAPE OF WBCS FROM THE LRS CHAMBER DURING A PORTION OF THE PROCEDURE. THERE ARE NO EVENTS (ADJUSTMENTS, CHANGES IN PUMP SPEED, SUBSTATE CHANGES,ETC.) IN THE PROCEDURE THAT CORRESPONDS WITH THE ONSET OF THE OVERLOADING OF THE LRS CHAMBER. BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE RULED OUT THAT THIS LEUKOREDUCTION FAILURE COULD BE DONOR RELATED. 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 WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS, OR CORRECTIVE AND PREVENTIVE ACTIONS BY TERUMO BCT QUALITY ASSURANCE. BASED ON THE RDF ANALYSIS, THE PLASMA LINE MAY HAVE BEEN OCCLUDED DURING A PORTION OF THE PROCEDURE. THE PLASMA LINE MAY BECOME OCCLUDED IF THE CENTRIFUGE COLLAR IS NOT LOADED INTO THE LATCH IN THE CORRECT ORIENTATION. UNDER THESE CONDITIONS, THE RBC LINE MAY LIE ON TOP OF THE PLASMA LINE AND, UNDER CERTAIN FLOW CONDITIONS, MAY CAUSE THE PLASMA LINE TO PINCH OFF. THIS IN TURN CAUSES HIGHER FLOW THROUGH THE LRS CHAMBER, WHICH MAY LEAD TO ELEVATED LEVELS OF WBCS IN THE PLATELET PRODUCT. OTHER POSSIBLE ROOT CAUSES WERE PROVIDED IN THE INITIAL REPORT FOR THIS EVENT. CORRECTIVE ACTION: 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
    195127 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC SET GKT TERUMO BCT 02V1213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other