BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2110083 · Received May 20, 2011

    Report

    Report Number
    1722028-2011-00170
    Event Type
    Other
    Date Received
    May 20, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 13, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT. THE DISPOSABLE SET WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 03T2122

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR