BEUDAMED
    FDA Adverse Event Other Summary report: N

    CT9000 ADV UC/MOB

    MDR report key: 625447 · Received August 8, 2005

    Report

    Report Number
    1518293-2005-00018
    Event Type
    Other
    Date Received
    August 8, 2005
    Date of Event
    July 19, 2005
    Report Date
    July 20, 2005
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SALES REPRESENTATIVE REPORTS THAT CUSTOMER CALLED AND REPORTED AN AIR INJECTION WITH THEIR CT9000ADV POWER INJECTOR. CUSTOMER WAS VERY VAGUE WITH DETAILS AND PROVIDES ONLY THE FOLLOWING INFORMATION AT THIS TIME. IN 2005, PATIENT WAS HAVING A CT OF THE ABDOMEN WITH CONTRAST. DURING INJECTION, THE ALARM SIGNIFYING THE INJECTOR HAD EXCEEDED WTH PSI LIMIT WENT OFF. THE TECHNOLOGIST STOPPED THE INJECTOR, AND NOTICED AIR IN THE HEART ON CT SCANS. PATIENT WAS ADMITTED TO HOSPITAL I.C.U. FOR OBSERVATION. IT IS KNOWN THAT THE CUSTOMER USES A 125ML PREFILLED CONTRAST MEDIA SYRINGE. PATIENT WAS SCANNED THE NEXT DAY AND AIR HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV UC/MOB CT 9000ADV POWER INJECTOR DXT LIEBEL-FLARSHEIM CO. CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization