BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBC II

    MDR report key: 1440028 · Received August 12, 2009

    Report

    Report Number
    1440028
    Event Type
    Malfunction
    Date Received
    August 12, 2009
    Date of Event
    July 24, 2009
    Report Date
    August 12, 2009
    Manufacturer
    STRYKER
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    DEVICE HAD CLOTTED SO STAFF WERE UNABLE TO AUTO-TRANSFUSE BACK TO PATIENT, THUS REQUIRING BLOOD TRANSFUSION. THIS WAS ONLY 3 HOURS AND 15 MINUTES POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II BLOOD CONSERVATION SYSTEM CAC STRYKER 225-28-916 CBC II *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NONE KNOWN.| NONE KNOWN.