BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 2925553 · Received January 22, 2013

    Report

    Report Number
    1722028-2013-00026
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 26, 2012
    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: THE DEVICE HISTORY RECORD (DHR) WAS 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. THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. ROOT CAUSE: SIGNALS IN THE RDF INDICATE THE POSSIBILITY THAT THE PLASMA LINE MAY HAVE BEEN PARTIALLY OCCLUDED DURING A PORTION OF THE RUN. 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 HEXHOLDER UNDER CERTAIN FLOW CONDITIONS, MAY CAUSE THE PLASMA LINE TO PINCH OFF. CORRECTIVE ACTION: ALGORITHMS HAVE BEEN INCORPORATED INTO THE SOFTWARE FOR THE TRIMA ACCEL SYSTEM. THESE ALGORITHMS 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 WBC'S 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 OPENED 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 RWBC TESTING, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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
    30912 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET GKT TERUMO BCT 10U0102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other