BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADD-ON-SET, 1.2 MICRON AIR ELIMINATING FILTER

    MDR report key: 29259 · Received January 5, 1996

    Report

    Report Number
    MW1008068
    Event Type
    Death
    Date Received
    January 5, 1996
    Date of Event
    December 20, 1995
    Report Date
    December 26, 1995
    Manufacturer
    MCGAW, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CARDIOPULMONARY ARREST DISCOVERED AND RESUSCITATION STARTED. PT WAS RECEIVNG 3 TPN VIA CATHETER PLACED IN RIGHT SUBCLAVIAN VEIN USING 1 PORT. NURSE NOTED TUBING OF FILTER HAD SEPARATED AT Y-SITE WITH SMALL AMOUNT OF TUBING LEFT ATTACHED TO CATHETER. THERE WAS BLOOD LOSS BUT THE AMOUNT COULD NOT BE QUANTIFIED. PT RESPONDED TO FLUIDS AND DRUG THERAPY, BUT REMAINED IN A VEGETATIVE STATE. EXPIRED 12/22/95. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD-ON-SET, 1.2 MICRON AIR ELIMINATING FILTER IV SET FPA MCGAW, INC. F5K249

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| L| S