BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWAN-GANZ VP CATHETER

    MDR report key: 33572 · Received May 10, 1996

    Report

    Report Number
    33572
    Event Type
    Death
    Date Received
    May 10, 1996
    Date of Event
    May 3, 1996
    Report Date
    May 8, 1996
    Manufacturer
    EDWARDS CRITICAL CARE DIV. 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 SWAN-GANZ VP CATHETER Implant CATHETER DYG EDWARDS CRITICAL CARE DIV. BAXTER HEALTHCARE CORP. 93A-831-7.SF

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death