BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOMAT CT9000 ADV INJECTOR

    MDR report key: 5302837 · Received September 15, 2004

    Report

    Report Number
    1518293-2004-00016
    Event Type
    Other
    Date Received
    September 15, 2004
    Date of Event
    August 19, 2004
    Report Date
    August 31, 2004
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER EVALUATED THE INJECTOR AND VERIFIED ADV OPERATION AND FOUND NO PROBLEMS. FSE VERIFIED THAT AIR CAUTION WARNINGS ARE OPERATIONAL.

    Description of Event or Problem · 1

    APPROX (B)(6) FEMALE PT HAD AN AIR INJECTION. THE CT INJECTOR WAS LOADED AND THE CT TECH WAITED TO LOAD THE INJECTOR UNTIL THE PT WAS IN THE ROOM (DEPARTMENT PROTOCOL). THE TUBING WAS OPEN, WITH CONTRAST DRIPPING INTO THE WASTE CAN. THE FIRST TECH LEFT THE STUDY TO A SECOND TECH. BEFORE INJECTION, THE LINE WAS RE-BLED TWO TIMES BY ANOTHER TECH. ONE HOUR LATER, THE STUDY WAS READ BY THE RADIOLOGIST AND AN UNK AMOUNT OF AIR WAS OBSERVED ON THE SCAN. THE PT DID NOT HAVE ANY PROBLEMS AS A RESULT OF THE AIR INJECTION. CUSTOMER WAS USING "Y" TUBING EVEN THOUGH THEY WERE NOT USING THE OPTISTAT IN CONJUNCTION WITH THE ADV. CUSTOMER BELIEVES AIR WAS INTRODUCED VIA THE TUBING OR INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT CT9000 ADV INJECTOR ANGIOGRAPHIC INJECTOR AND SYRINGE DXT LIEBEL-FLARSHEIM CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other