BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL LRS PLT. PLS, RBC, AUTO PAS SET

    MDR report key: 2223278 · Received August 16, 2011

    Report

    Report Number
    1722028-2011-00287
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 REQUESTED THAT THE DATA LOGS BE ANALYZED TO DETERMINE A CAUSE FOR THE HIGHER THAN EXPECTED WHITE BLOOD CELL COUNT IN THE COLLECTED BLOOD PRODUCT. PATIENT IDENTIFIER, AGE, AND GENDER ARE NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL LRS PLT. PLS, RBC, AUTO PAS SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 04T3128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other