BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 4061178 · Received September 4, 2014

    Report

    Report Number
    1722028-2014-00358
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 12, 2014
    Report Date
    August 8, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE RUN DATA FILE DO NOT INDICATE A CONCLUSIVE CAUSE FOR THE GREATER THAN EXPECTED RWBC CONTENT IN THE PLATELET PRODUCT REPORTED FOR THIS COLLECTION. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED IN THE RUN DATA FILE AND THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. WHILE THE TRIMA ACCEL SYSTEM IS TYPICALLY ROBUST AGAINST NUMEROUS FLOW ALERTS AND ADJUSTMENTS IT IS POSSIBLE THAT THE HIGH NUMBER OF ALERTS OCCURING IN A SHORT PERIOD OF TIME EARLY IN THE PROCEDURE DISRUPTED THE STEADY-STATE OF THE SYSTEM AND CONTRIBUTED TO THE HIGHER THAN EXPECTED RWBC CONTENT REPORTED FOR THIS PROCEDURE. BASED ON THE AVAILABLE INFORMATION IT IS ALSO POSSIBLE THAT THIS LEUKOREDUCTION FAILURE COULD BE DONOR-RELATED. IT ALSO CANNOT BE RULED OUT THAT A SAMPLING, CALCULATION, OR OTHER PROCESS ERROR MAY HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED RWBC CONTENT IN THE PLATELET PRODUCT. INVESTIGATION IS 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 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.

    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
    540377 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, RBC SET GKT TERUMO BCT 05W3108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other