BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 6036704 · Received October 18, 2016

    Report

    Report Number
    1722028-2016-00567
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 18, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK150321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COLLECTION SET WAS RETURNED FOR INVESTIGATION. UPON INSPECTION OF THE SET, THERE WERE NO ISSUES FOUND WITH THE SET. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. RDF ANALYSIS CONFIRMED THAT A ¿TUBING SET TYPEERROR¿ ALERT WAS GENERATED AFTER THE TUBING SET WAS LOADED. FOLLOWING THE TUBING SET TYPE ERROR ALERT, THE OPERATOR RE-LOADED THE TUBING SET AND PASSED THE TUBING SET TEST; HOWEVER, BASED ON THE COMPLAINT DESCRIPTION AIR WAS NOTED TO BE IN THE SAMPLE BAG AND THE OPERATOR TERMINATED THE PROCEDURE. ROOT CAUSE: BASED ON SIGNALS IN THE RDF, ROOT CAUSE WAS DETERMINED TO BE PARTIAL OCCLUSION OF THE SAMPLE BAG LINE CLAMP. POSSIBLE CAUSES FOR THIS INCLUDE, BUT ARE NOT LIMITED TO, A MISASSEMBLY OF THE TUBING WITHIN THE CLAMP OR A CLAMP INADVERTENTLY BEING LEFT OPEN. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF AIR IN SAMPLE BAG.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SETUP FOR A COLLECTION PROCEDURE, THEY RECEIVED A 'PRESSURETEST ERROR' ALARM AND NOTED AIR IN THE SAMPLE BAG. THE OPERATOR TERMINATED THE PROCEDURE PRIOR TO CONNECTING A DONOR. NO DONOR WAS CONNECTED AT THE TIME OF THE EVENT, THEREFORE, NO PATIENT (DONOR) INFORMATION IS REASONABLY KNOWN. THIS PRODUCT IS NOT AVAILABLE WITHIN THE US, BUT THIS REPORT IS BEING FILED DUE TO AN ALLEGED FAILURE THAT COULD OCCUR ON A SIMILARLY MARKETED DEVICE PLATFORM CLEARED FOR USE BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688360 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET GKT TERUMO BCT 05Z0405

    Patients

    Seq Age Sex Outcome Treatment
    1 Other