BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3080861 · Received April 26, 2013

    Report

    Report Number
    1722028-2013-01154
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 28, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK970005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT,THEREFORE A DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE. NO FURTHER INFORMATION REGARDING THIS EVENT WAS PROVIDED BY THE CUSTOMER. ROOT CAUSE: THE DISPOSABLE SET WAS UNAVAILABLE FOR ROOT CAUSE DETERMINATION. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED LEUKOREDUCTION FAILURE REMAINS UNDETERMINED AT THIS TIME.

    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)(4). 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
    183054 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC AUTO PAS SET GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other