BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD CPS SYSTEM

    MDR report key: 19217 · Received November 1, 1994

    Report

    Report Number
    19217
    Event Type
    Death
    Date Received
    November 1, 1994
    Date of Event
    October 26, 1994
    Report Date
    October 27, 1994
    Manufacturer
    C.R. BARD, INC.
    Product Code
    DTZ
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OXYGENATOR BEGAN LEAKING AND PT BEGAN DROPPING BLOOD PRESSURE AND THUS EXPIRED PRIOR TO BEING ABLE TO CHANGE TO NEW OXYGENATOR UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD CPS SYSTEM OXYGENATOR DTZ C.R. BARD, INC. 14320-11

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death