BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADD-ON-SET

    MDR report key: 29884 · Received January 9, 1996

    Report

    Report Number
    29884
    Event Type
    Death
    Date Received
    January 9, 1996
    Date of Event
    December 20, 1995
    Report Date
    January 4, 1996
    Manufacturer
    MCGAW, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIOPULMONARY ARREST DISCOVERED AND RESUSCITATION STARTED. PT WAS RECEIVING 3 IN 1 TPN VIA CATHETER PLACED IN THE RIGHT SUBCLAVIAN USING 1 PORT. NURSE NOTED TUBING OF FILTER HAD SEPARATED Y-SITE WITH SMALL AMOUNT OF TUBING LEFT ATTACHED TO CATHETER. THERE WAS BLOOD LOSS, BUT THE AMOUNT COULD NOT BE QUANTITATED. PT RESPONDED TO FLUID AND DRUG THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD-ON-SET 2 MICRON AIR ELIMINATING FILTER AND INJECTION SITE FPA MCGAW, INC. F5K249

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death