BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAXTER SWAN GANZ VP CATHETER

    MDR report key: 35128 · Received July 23, 1996

    Report

    Report Number
    35128
    Event Type
    Death
    Date Received
    July 23, 1996
    Date of Event
    May 3, 1996
    Report Date
    May 8, 1996
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CONNECTION BETWEEN SHEATH AND CATHETER BECAME DISCONNECTED CAUSING LINE TO LEAK. CARE PROVIDER REMOVED LINE WITHOUT REMOVING SHEATH AND APPLYING PRESSURE, POSSIBLY CAUSING AN AIR EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER SWAN GANZ VP CATHETER Implant EDWARDS SWAN-GANZ VP CATHETER DYG BAXTER HEALTHCARE CORP. 93A-831-7.SF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death