BEUDAMED
    FDA Adverse Event Other Summary report: N

    CT9000 ADV DOMESTIC BASIC SYS

    MDR report key: 673682 · Received February 7, 2006

    Report

    Report Number
    1518293-2006-00003
    Event Type
    Other
    Date Received
    February 7, 2006
    Date of Event
    January 3, 2006
    Report Date
    February 1, 2006
    Manufacturer
    LIEBEL-FLARSHEIM, CO
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS FEMALE HAVING CT CHEST WITH IV CONTRAST. VASCULAR ACCESS THROUGH RIGHT AC VIA THE FOLLOWING METHOD; B-D INSYTE AUTOGUARD, CONNECTED TO A BAXTER INTERLINK, CONNECTED TO A LEVER LOK CANNULA, CONNECTED TO COILED TUBING CONNECTED TO THE INJECTOR SYRINGE. INJECTION PROTOCOL WAS 2.5ML RATE FOR 100ML VOLUME. INJECTION STARTED. AS THE TECHNOLOGIST OBSERVED, IT WAS NOTICED THAT THE INJECTION WAS INFILTRATING, THE TECHNOLOGIST IMMEDIATELY STOPPED THE IV INFECTION. APPROXIMATELY 30ML INFILTRATED. HOT PACK APPLIED ON AREA. PATIENT WAS RELEASED WITH FAMILY AND INSTRUCTIONS TO WATCH AREA AND KEEP WARM PACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV DOMESTIC BASIC SYS ANGIOGRAPHIC POWER INJECTOR DXT LIEBEL-FLARSHEIM, CO CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention