BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 6077308 · Received November 3, 2016

    Report

    Report Number
    1722028-2016-00594
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK150321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE OBSERVED LEUKOREDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND A CONCLUSIVE CAUSE FOR THE HIGHER-THAN-EXPECTED WBC CONTENT REPORTED IN THE RBC PRODUCT FOR THIS COLLECTION. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED AND THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. BASED ON THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE FILTER WAS UNLOADED FROM THE FILTER BRACKET AND LOADED AGAIN DURING RBC COLLECTION OR RBC ADDITIVE SOLUTION ADDITION, WHICH COULD HAVE A SIMILAR AFFECT TO ¿SQUEEZING¿ THE FILTER WHEN USING A GRAVITY DRAIN SYSTEM. IT IS ALSO POSSIBLE THAT THE REPORTED RESULTS COULD BE ATTRIBUTED TO AN ISSUE WITH THE FILTER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DEVICE HISTORY RECORDS (DHR) WERE 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 RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND A CONCLUSIVE CAUSE FOR THE HIGHER-THAN-EXPECTED WBC CONTENT REPORTED IN THE RBC PRODUCT FOR THIS COLLECTION. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED AND THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. BASED ON THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE FILTER WAS UNLOADED FROM THE FILTER BRACKET AND LOADED AGAIN DURING RBC COLLECTION OR RBC ADDITIVE SOLUTION ADDITION, WHICH COULD HAVE A SIMILAR AFFECT TO ¿SQUEEZING¿ THE FILTER WHEN USING A GRAVITY DRAIN SYSTEM. IT IS ALSO POSSIBLE THAT THE REPORTED RESULTS COULD BE ATTRIBUTED TO AN ISSUE WITH THE FILTER. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    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 RED BLOOD CELL (RBC) PRODUCT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL (RWBC) TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE RED BLOOD CELL COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728759 TRIMA ACCEL TRIMA ACCEL RBC, PLS, AUTORBC SET GKT TERUMO BCT 07Z2115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other