BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 2970041 · Received February 20, 2013

    Report

    Report Number
    1722028-2013-00951
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 23, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE RDF INDICATE THE POSSIBILITY THE PLASMA LINE MAY HAVE BEEN PARTIALLY OCCLUDED DURING A PORTION OF THE RUN. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. THE OCCLUSION OF THE PLASMA LINE CAUSES THE PLASMA LINE TO NO LONGER CONTRIBUTE TO THE PLATELET PUMP, WHICH IN TURN CAUSES THE FLOW THROUGH THE LEUKOREDUCTION SYSTEM (LRS) CHAMBER TO BE HIGHER THAN THE SYSTEM EXPECTS. THIS CAN CAUSE WBCS TO ESCAPE THE LRS CHAMBER AND END UP IN THE PRODUCT BAG. THE ORIENTATION OF THE TUBING AS LOADED IN THE CENTRIFUGE HEX HOLDER UNDER CERTAIN FLOW CONDITIONS,MAY CAUSE THE PLASMA LINE TO PINCH OFF. ALGORITHMS HAVE BEEN INCORPORATED INTO THE SOFTWARE FOR THE TRIMA ACCEL SYSTEM. THE SEALGORITHMS RECOGNIZE A POTENTIAL ELEVATED WBC COUNT DUE TO THE FAILURE MODE WITNESSED DURING THIS INVESTIGATION. THE SOFTWARE WILL FLAG THE PROCEDURE TO MEASURE OR "VERIFY WBCS IN THE PLATELET PRODUCT". THE NEW ALGORITHMS WERE MADE AVAILABLE AS PART OF THE 6.1.2 TRIMA SOFTWARE UPGRADE,AND CAN BE ENABLED UPON APPROVAL. AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF ELEVATED WBCS 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. 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
    74165 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET GKT TERUMO BCT 09U0101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other