BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS LIFE SCIENCES

    MDR report key: 376458 · Received February 12, 2002

    Report

    Report Number
    376458
    Event Type
    Death
    Date Received
    February 12, 2002
    Date of Event
    January 26, 2002
    Report Date
    February 6, 2002
    Manufacturer
    EDWARDS LIFE SCIENCES
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A PULMONARY ARTERY CATHETER PLACED THROUGH A LEFT INTERNAL JUGULAR INTRODUCER. PT HAD BEEN ON HEPARIN (400 CC/HR INFUSION). THE HEPARIN WAS DISCONTINUED AT 09:00 AND THE PA LINE PLACEMENT WAS AT 15:00. PT WAS HEMODYNAMICALLY UNSTABLE ON LEVOPHED AT 23MCG IN ATRIAL FIBRILLATION. FOLLOWING FLOATATION OF THE PA-LINE INTO PCWP THE BALLOON WAS DEFLATED. THE MONITOR CONTINUED TO SHOW A PCWP TRACING. THE CATHETER WAS PULLED BACK A COUPLE OF CENTIMETERS AND THE BLOOD PRESSURE DROPPED ACUTELY TO 50MM SYSTOLIC. BRIGHT RED BLOOD WAS NOTED IN THE ETT AND CPR/RESUSCITATION STARTED. THE PT EXPIRED AFTER 20 MIN EFFORT. PA PRESSURE WAS 66/33 WHEN FLOATED THROUGH THE PULMONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFE SCIENCES VIP PLUS TRI-LUMEN PULMONARY ARTERY CATHETER DYG EDWARDS LIFE SCIENCES 834HF75 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death