BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD STELLANT CT INJECTOR

    MDR report key: 20532187 · Received October 25, 2024

    Report

    Report Number
    20532187
    Event Type
    Death
    Date Received
    October 25, 2024
    Date of Event
    August 1, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS A LEVEL 1 TRAUMA: PEDESTRIAN V. VEHICLE. CXR (CHEST X-RAY) IN ER (EMERGENCY ROOM) WAS SUSPICIOUS FOR AORTIC INJURY AND FAST (FOCUSED ASSESSMENT WITH SONOGRAPHY FOR TRAUMA) SCAN WAS POSITIVE. PATIENT WAS TAKEN TO CT FOR CT WITH IV CONTRAST, BUT THE CONTRAST INJECTOR MALFUNCTIONED. MD ORDERED CT OF C/A/P (CHEST, ABDOMEN, AND PELVIS) AND T (THORACIC) AND L (LUMBAR) SPINE W/O CONTRAST, LIMITING THE DIAGNOSTIC ABILITY OF VASCULAR INJURIES. PATIENT WAS TAKEN TO OR (OPERATING ROOM) FOR EXPLORATORY LAPAROTOMY AND THEN TO STICU (SURGICAL TRAUMA INTENSIVE CARE UNIT). PATIENT ARRESTED IN STICU AND WAS UNABLE TO BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026034 MEDRAD STELLANT CT INJECTOR INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BAYER MEDICAL CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death