BEUDAMED
    FDA Adverse Event Other Summary report: N

    CT 9000 ADV INJECTOR

    MDR report key: 285589 · Received July 10, 2000

    Report

    Report Number
    1518293-2000-00009
    Event Type
    Other
    Date Received
    July 10, 2000
    Date of Event
    June 28, 2000
    Report Date
    July 10, 2000
    Manufacturer
    LIEBEL-FLARSHEIM COMPANY
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A THORACIC/ABDOMINAL CT SCAN, INJECTOR WAS PROGRAMMED FOR 100ML CONTRAST DELIVERY. AFTER REMOVING THE CURLY CONNECTOR FROM ITS HOLDER, THE RADIOGRAPHER NOTICED THAT CONTRAST WAS BEING EJECTED ON ITS OWN WITHOUT THE OPERATOR ACTIVATING THE START KEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT 9000 ADV INJECTOR ANGIOGRAPHIC INJECTOR & SYRINGE DXT LIEBEL-FLARSHEIM COMPANY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other