BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACIST CONTRAST INJECTOR

    MDR report key: 1904228 · Received November 15, 2010

    Report

    Report Number
    MW5018238
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE CONCLUSION OF THE LV ANGIOGRAM, THE CATHETER WAS FLUSHED FOR POST PRESSURE MEASUREMENT. THE TECHNOLOGIST COULD HEAR THE SYSTEM FLUSHING AND UPON COMPLETION THE TECHNOLOGIST NOTED THE PRESSURE WAS FLAT LINED MEASURING OVER 300. THE TECHNOLOGIST ASKED WHAT HAPPENED TO MY PRESSURE AND THE MD LOOKED AT THE CATHETER/TUBING AND SAW THE AIR FILLED TUBING AND IMMEDIATELY REMOVED THE CATHETER FROM THE BODY. THE PT DID NOT SHOW ANY UNEXPECTED ADVERSE REACTION. SUSPECT AIR SENSORS ON INJECTOR SYSTEM FAILED TO SENSE AIR AND DID NOT STOP THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST CONTRAST INJECTOR ACIST CONTRAST INJECTOR DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 1074

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening