BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADULT-PED WET W/PRE-ATTACHED ATS BAG

    MDR report key: 111285 · Received August 5, 1997

    Report

    Report Number
    1221601-1997-00003
    Event Type
    Death
    Date Received
    August 5, 1997
    Date of Event
    July 1, 1997
    Report Date
    August 4, 1997
    Manufacturer
    DEKNATEL, INC.
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA BECAUSE OF AN AIR LEAK IN THE SYSTEM DUE TO A DAMAGED AND BROKEN TUBING PORT. THE BROKEN PORT WAS THE PORT WHICH CONNECTS THE PLEUR-EVAC UNIT TO THE AUTOTRANSFUSION BAG. THE PATIENT WHO WAS HOSPITALIZED DUE TO MULTISYSTEM FAILURE EXPIRED ON 7/3/97. THE HOSPITAL DOES NOT BELIEVE THE A-7050-ATS UNIT IS RESPONSIBLE FOR THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT-PED WET W/PRE-ATTACHED ATS BAG CHEST DRAINAGE WITH ATS KDQ DEKNATEL, INC. A-7050-ATS 216717

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R