BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE CARDIOVASCULAR

    MDR report key: 509116 · Received January 22, 2004

    Report

    Report Number
    MW1030922
    Event Type
    Death
    Date Received
    January 22, 2004
    Date of Event
    January 5, 2004
    Report Date
    January 22, 2004
    Manufacturer
    COBE CARDIOVASCULAR, INC
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BRAT 2 - MACHINE USED IN SURGICAL CASE IN WHICH PT ARRESTED WITHIN MINUTES OF RECEIVING 250 ML AUTOLOGOUS BLOOD, PROCESSED IN THIS MACHINE. NO MALFUNCTION OR CAUSES COULD BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE CARDIOVASCULAR CELL SAVER CAC COBE CARDIOVASCULAR, INC BRAT 2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| O