BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOMAT CT9000 ADV INJECTOR

    MDR report key: 524378 · Received February 10, 2004

    Report

    Report Number
    1518293-2004-00003
    Event Type
    Other
    Date Received
    February 10, 2004
    Date of Event
    February 4, 2004
    Report Date
    February 5, 2004
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A CT CHEST. DURING THE INJECTION, THE TECHNOLOGIST NOTICED THE CONTRAST STARTED OUT BRIGHT, BUT QUICKLY FADED. THIS INJECTION WAS THROUGH AN EXISTING CENTRAL VENOUS LINE. THE TECH QUICKLY STARTED A NEW PERIPHERAL LINE AND LOADED A NEW SYRINGE AND RESTARTED THE INJECTION/PROCEDURE. DURING THE RADIOLOGIST REVIEW OF THE IMAGES, IT WAS ESTIMATED THAT APPROX 30-40CC AIR HAD BEEN INJECTED. THE PATIENT EXPERIENCED NO SYMPTOMS AND WAS RETURNED TO THEIR CORONARY CARE UNIT BED WHERE PT WAS MONITORED. THE INITIAL SYRINGE WAS RETRIEVED AND IT WAS NOTED THAT THE SYRINGE WAS COMPLETELY EMPTY, WHEN NORMALLY THEY WOULD HAVE ABOUT 10CC LEFT IN THE SYRINGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other