BEUDAMED
    FDA Adverse Event Other Summary report: N

    CT9000 ADV DOMESTIC BASIC SYS

    MDR report key: 1053289 · Received May 16, 2008

    Report

    Report Number
    1518293-2008-00074
    Event Type
    Other
    Date Received
    May 16, 2008
    Date of Event
    September 24, 2004
    Report Date
    September 27, 2004
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT: PER CUSTOMER, ONLY 1 CC OF AIR WAS REPORTED AND WAS FOUND WELL AFTER PT WAS RELEASED. NO COMPLAINTS OR ISSUES WERE REPORTED BY THE PT. CUSTOMER REPORTS THAT THEY DID NOT NEED A SERVICE CALL TO CHECK BUT THE UNIT AS THEY DO NOT FEEL IT WAS A PROBLEM WITH THE INJECTOR.

    Description of Event or Problem · 1

    IN 2004, DURING A CT PROCEDURE, THE PT RECEIVED A SLIGHT AMOUNT OF AIR. THE IV WAS STARTED IN RADIOLOGY WHILE THE PT WAS ON THE CT TABLE. THE SYRINGE WAS LOADED AND THE TUBING CONNECTED. THE LINE WAS PURGED OF AIR AND CONNECTED TO THE PATIENT'S IV. DURING THE READING OF THE CT IMAGES, THE RADIOLOGIST NOTED AIR ON THE IMAGES. RADIOLOGIST DOCUMENTED THE AMOUNT OF AIR AS 1 CM. NO INJECTOR SERVICE WAS REQUESTED. THE PT SUFFERED NO SYMPTOMS FROM THIS EVENT. CUSTOMER INDICATED THAT THEY DID NOT FEEL THERE WAS A PROBLEM WITH THE INJECTOR AND THAT IT WAS STILL IN SERVICE. THEY DID NOT WANT A SERVICE CALL TO CHECK OUT THE UNIT AND FELT THAT IT WAS UN-NECESSARY. INJECTOR IS NOT SUSPECTED AND IS STILL IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 ADV DOMESTIC BASIC SYS CT POWER INJECTOR SYSTEM IZQ LIEBEL-FLARSHEIM CO. CT9000 ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other