BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS LIFE SCIENCES

    MDR report key: 425719 · Received October 29, 2002

    Report

    Report Number
    425719
    Event Type
    Death
    Date Received
    October 29, 2002
    Date of Event
    October 21, 2002
    Report Date
    October 28, 2002
    Manufacturer
    EDWARDS LIFE SCIENCES
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT S/P MULTIPLE STAB WOUNDS AND 2 SURGICAL PROCEDURES: 1) EX LAP: REPAIR OF 2 LIVER LACERATIONS, REPAIR OF 3 GASTRIC LACERATIONS, REPAIR OF INFERIOR VENA CAVA LACERATION, LEFT ANTERIOR/LATERAL THORACOTOMY PLACEMENT OF SILASTIC SHEETING. 2) LEFT UPPER EXTREMITY FASCIOTOMY. HAD LEFT SUBCLAVIAN CENTRAL LINE PLACED IN SICU. WIRE THREADED EASILY AFTER 3-4 ATTEMPTS TO FIND VEIN. GOOD BLOOD RETURN AND CENTRAL VENOUS PRESSURE (CVP) WAVE FORM WITH CVP PRESSURE INITIALLY 55CM. FOLLOWING LEFT CHEST TUBE PLACEMENT, CVP DECREASED TO 12CM. RETURNED TO OPERATING ROOM FOR EMERGENCY THORACOTOMY DUE TO INCREASED BLOOD IN LEFT CHEST TUBE. EXPIRED IN OPERATING ROOM - CHEST EXPLORATION REVEALED TIP OF CVP CATHETER PROTRUDING THROUGH SUBCLAVIAN VEIN. CASE REFERRED TO MEDICAL EXAMINER AND ACCEPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFE SCIENCES AVA-HF ADVANCED VENOUS ACCESS CATH DQO EDWARDS LIFE SCIENCES AVA-HF *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death NO PA LINE WAS FLOATED THROUGH THE AVA.