BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD STELLANT FLEX CT INJECTION SYSTEM

    MDR report key: 12149095 · Received July 12, 2021

    Report

    Report Number
    12149095
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 7, 2021
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ELDERLY PATIENT WAS ON THE TABLE FOR HER CT SCAN EXAM IN RADIOLOGY. THE TECHNOLOGISTS HAD COMPLETED A SALINE INJECTION WITH THE BAYER/MEDRAD POWER INJECTOR. WHEN THEY WENT TO INJECT THE ACTUAL CONTRAST ABOUT FIVE SECONDS INTO THE INJECTION, IT STOPPED INJECTING, AND THEY HEARD A POPPING SOUND. THEY IMMEDIATELY STOPPED THE SCAN AND WENT IN TO ASSESS THE SITUATION. THEY OBSERVED THAT TH ACTUAL SYRINGE WAS BROKEN AND WAS HANGING FROM THE INJECTOR STILL CONNECTED TO THE TUBING WHILE THE BOTTOM PLASTIC WAS ACTUALLY STUCK IN THE INJECTOR. THE PATIENT WAS NOT HARMED. SHE WAS MOVED TO ANOTHER ROOM SO THAT HER SCAN COULD BE COMPLETED. THE BAYER/MEDRAD INJECTOR IS UNDER SERVICE WARRANTY. THE VENDOR WAS CONTACTED IMMEDIATELY, AND THIS EVENT WAS REPORTED TO THE VENDOR. WE ARE UNABLE TO USE THE INJECTOR UNTIL APPROPRIATELY REPAIRED. WE DO HAVE A PORTABLE INJECTOR, WHICH HAS BEEN CONNECTED SO THAT WE MAY CONTINUE TO PROVIDE CARE TO OTHER PATIENTS IN THIS SCAN ROOM. MANUFACTURER RESPONSE FOR CONTRAST INJECTION DEVICE, MEDRAD STELLANT FLEX CT INJECTION SYSTEM (PER SITE REPORTER): PRODUCT UNDER WARRANTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046581 MEDRAD STELLANT FLEX CT INJECTION SYSTEM INJECTOR, CONTRAST MEDIUM, AUTOMATIC IZQ BAYER MEDICAL CARE INC. FLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA