BEUDAMED
    FDA Adverse Event Death Summary report: N

    MED RAD INJECTOR

    MDR report key: 102148 · Received June 14, 1997

    Report

    Report Number
    102148
    Event Type
    Death
    Date Received
    June 14, 1997
    Date of Event
    February 18, 1997
    Report Date
    June 14, 1997
    Manufacturer
    MED RAD TECHNOLOGY
    Product Code
    DXT
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MED RAD INJECTOR IMPROPERLY PREPARED FOR USE DURING CARDIAC CATHETERIZATION PROCEDURE. INITIALLY NOT LOADED WITH CONTRAST. PHYSICIAN UNAWARE. CONNECTOR TUBING NOT USED PER PHYSICIAN PREFERENCE. APPROXIMATELY 15 CC AIR INJECTED INTO PATIENT'S HEART CAUSING AIR EMBOLUS AND SUBSEQUENT DEATH OF PATIENT. USER ERROR MAKES THIS INCIDENT A MANDATORY REPORT PER RE-EXAMINATION OF INCIDENT ON 06/16/97. INJECTOR FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED RAD INJECTOR INJECTOR DXT MED RAD TECHNOLOGY 24036 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death