BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3121504 · Received May 21, 2013

    Report

    Report Number
    1722028-2013-01213
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 24, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATON, EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE OBSERVED LEUKOREDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME. 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. BASED ON THE AVAILABLE INFORMATION IT IS POSSIBLE THAT THIS LEUKOREDUCTION FAILURE CBE 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.

    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
    224532 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET GKT TERUMO BCT 03V2904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other