BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAXTER

    MDR report key: 117932 · Received September 4, 1997

    Report

    Report Number
    117932
    Event Type
    Death
    Date Received
    September 4, 1997
    Date of Event
    November 8, 1996
    Report Date
    July 15, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP. (AKA ALLEGIANCE HEALTH CARE)
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RIGHT IJ SWAN GANZ CATHETER INSERTED ON 11/7/96 FOR HEMODYNAMIC MONITORING. CHEST X-RAY OBTAINED AND CONFIRMED PROPER POSITIONING. PT UNDERWENT LEFT HEMICOLECTOMY ON 11/8/96. AT 11;50 PM, APPROX. 10 MINUTES AFTER THE BALLOON HAD BEEN INFLATED TO OBTAIN PRESSURES, PT DEVELOPED HEMOPYTYSIS FOLLOWED BY CARDIOPULMONARY ARREST. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER SWAN GANZ THERMODILUTION CATHETER DYG BAXTER HEALTHCARE CORP. (AKA ALLEGIANCE HEALTH CARE) 131 HF7 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death