BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC II

    MDR report key: 334776 · Received May 22, 2001

    Report

    Report Number
    334776
    Event Type
    Injury
    Date Received
    May 22, 2001
    Date of Event
    March 19, 2001
    Report Date
    March 23, 2001
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE ATTEMPTED TO REINFUSE CONSTAVAC DRAINAGE BUT DEVICE FAILED (PUMP) TO RELEASE FLUID. BLOOD BAG SEPARATED FROM DEVICE BUT DEVICE STILL FAILED TO DRAIN. PT RECEIVED AUTOLOGOUS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24258 CBC II APPARATUS, AUTO TRANSFUSION CAC STRYKER INSTRUMENTS 0225-028-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention