BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT 9000 INJECTOR

    MDR report key: 101454 · Received June 27, 1997

    Report

    Report Number
    101454
    Event Type
    Injury
    Date Received
    June 27, 1997
    Date of Event
    May 17, 1997
    Report Date
    May 21, 1997
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    50 YR OLD MULT TRAUMA FOR CT OF ABDOMEN, AIR BOLUS OCCURRED DURING INJECTION OF DYE. PT TRANSFERRED TO ICU AND INTUBATED ON VENT. POWER INJECTOR NEEDS SOME SAFETY MECHANISMS IN PLACE SO THE STAFF CAN'T GIVE AIR INSTEAD OF DYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT 9000 INJECTOR DIGITAL CT INJECTOR DXT LIEBEL-FLARSHEIM CO. 800001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention