BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS GERMAN SET

    MDR report key: 2253139 · Received August 31, 2011

    Report

    Report Number
    1722028-2011-00104
    Event Type
    Other
    Date Received
    August 31, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 5, 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 ALLEGED FILTER/LRS MALFUNCTION, RESULTING IN AN ELEVATED WBC COUNT DURING A PLATELET PROCEDURE. THE DISPOSABLE IS NOT AVAILABLE FOR RETURN. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WHITE BLOOD CELL TESTING, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THIS REPORT IS BEING FILED DUE TO AN ALLEGED DEVICE MALFUNCTION THAT HAS 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 05T2123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other