BEUDAMED
    FDA Adverse Event Death Summary report: N

    ISOVUE 300

    MDR report key: 563793 · Received September 29, 2004

    Report

    Report Number
    563793
    Event Type
    Death
    Date Received
    September 29, 2004
    Date of Event
    September 11, 2004
    Report Date
    September 29, 2004
    Manufacturer
    BRACCO DIAGNOSTICS, INC.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO ED, EMERGENCY DEPARTMENT, FOR DYSPNEA. CT, COMPUTERIZED TOMOGRAPHY, SCAN OF CHEST WITH CONTRAST ORDERED. INTRAVENOUS CONTRAST, ISOVUE 300 WITH EXPIRATION DATE OF 3/07 WAS ADMINISTERED VIA THE AUTOMATIC CONTRAST INJECTOR. STANDARD DOSING PROTOCOL WAS FOLLOWED. COMPUTERIZED SETTINGS WITH COMPUTERIZED INJECTOR RATE. SOLUTION IS SET UP AND PLACED IN THE INJECTOR ACCORDING TO PROTOCOL. FROM THE SET UP, THE INJECTION TIME IS DETERMINED. PROCEDURE COMPLETED. ON RETURN TO ED PATIENT EXPERIENCED PULSELESSNESS AND APNEA. FULL ACLS, ADVANCED CARDIAC LIFE SUPPORT, RESUSCITATION ADMINISTERED WITHOUT RESPONSE. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOVUE 300 CONTRAST MEDIA IZQ BRACCO DIAGNOSTICS, INC. * 4C4931
    2 STELLANT CONTRAST INJECTOR IZQ MEDRAD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death