BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFE TRAC DUAL WIRE INSERTION KIT

    MDR report key: 501636 · Received December 11, 2003

    Report

    Report Number
    501636
    Event Type
    Death
    Date Received
    December 11, 2003
    Date of Event
    September 26, 2003
    Report Date
    December 10, 2003
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PROCEDURE FOR PLACEMENT OF A TEMPORARY DIALYSIS CATHETER. SHORTLY AFTER THE CATHETER WAS PLACED, THE PT COMPLAINED OF SHORTNESS OF BREATH, BECAME UNRESPONSIVE AND PULSELESS. ACLS PROCESS FOLLOWED. NEEDLE THORACOTOMY DONE DUE TO SLIGHTLY DIMINISHED BREATH SOUNDS ON RIGHT SIDE. THIS WAS NEGATIVE IN FINDINGS-NO AIR RUSH. ECHOCARDIOGRAM DONE SHOWING NO EVIDENCE OF PERICARDIAL EFFUSION. AGGRESSIVE RESUSCITATIVE EFFORTS TAKEN WITH NO PULSES AND NO RESPONSE. ASYSTOLIC AND PRONOUNCED DEAD. NO AUTOPSY PERFORMED. PHYSICIAN PERFORMING PROCEDURE AND ATTENDING DO NOT BELIEVE CATHETER RESULTED IN DEATH. DEATH CERTIFICATE INDICATES CAUSES: 1. CHF. 2. CARDIOPULMONARY ARREST. 3. END STAGE RENAL DISEASE. SIGNED BY ATTENDING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE TRAC DUAL WIRE INSERTION KIT CATHETERIZATION KIT DYB SPIRE BIOMEDICAL, INC. XDWIK28 99357994

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death