BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PIT, PLS, RBC SET

    MDR report key: 2211370 · Received August 4, 2011

    Report

    Report Number
    1722028-2011-00256
    Event Type
    Other
    Date Received
    August 4, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CARDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK110009
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, POST-PROCEDURE, THE BLOOD SAMPLE FROM THE CASSETTE ALLEGEDLY PRESENTED HEMOLYSIS. PT INFO AND THE DATE OF THE EVENT ARE NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFO PROVIDED AT THIS TIME TO DETERMINE IF A DEVICE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PIT, PLS, RBC SET AUTOMATED BLOOD CELL SEPARATOR LKN CARDIANBCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1