BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBC II

    MDR report key: 473446 · Received July 22, 2003

    Report

    Report Number
    2648666-2003-20003
    Event Type
    Malfunction
    Date Received
    July 22, 2003
    Date of Event
    June 24, 2003
    Report Date
    June 27, 2003
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO UNITS DID NOT REINFUSE ON A SINGLE PT. PT HAD TO RECEIVE DONOR TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II APPARATUS, AUTO TRANSFUSION CAC STRYKER INSTRUMENTS 0225-028-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR