BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, GERMAN SET

    MDR report key: 2253137 · Received August 29, 2011

    Report

    Report Number
    1722028-2011-00306
    Event Type
    Other
    Date Received
    August 29, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WHITE BLOOD CELL COUNT IN THE COLLECTED BLOOD PRODUCT WAS TO HIGH, AND ALLEGED A FILTER/LEUKOREDUCTION SYSTEM FAILURE. THE DISPOSABLE SET WAS DISPOSED OF BY THE CUSTOMER, THEREFORE IT IS UNAVAILABLE TO BE RETURNED FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO AN ALLEGED DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, GERMAN SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 05T2103

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR