BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD STELLANT CT INJECTION SYSTEM

    MDR report key: 8419782 · Received March 14, 2019

    Report

    Report Number
    8419782
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    August 16, 2018
    Report Date
    February 26, 2019
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CT WAS COMPLAINING THAT THE INJECTOR IN ROOM 1 WAS PRESSURE LIMITING WHEN THE FLOW RATE WAS SET TO 4ML/SEC. THE SYSTEM DECREASES THE FLOW RATE TO KEEP THE PRESSURE JUST BELOW THE ALARM THRESHOLD. THIS DECREASED FLOW RATE WAS CAUSING IMAGE QUALITY PROBLEMS. WE SWITCHED THE INJECTORS BETWEEN ROOMS 1 & 2 AND STILL GOT HIGH PRESSURE ALARMS IN ROOM 1. REPLACED ROOM 1 WITH THE SPARE SYSTEM AND STILL GOT ALARMS. I CALLED TECH SUPPORT AND THEIR OPINION WAS THAT SOMETHING HAD TO HAVE CHANGED WITH THE DISPOSABLES, NEEDLES, OR TECHNIQUE. THE STAFF CLAIMED NOTHING HAD CHANGED. SO WE SUSPECTED A BAD LOT OF DISPOSABLES BUT ALL THE SITES IN THE NETWORK WERE USING DISPOSABLES FROM THE SAME SUPPLY. WE WERE THE ONLY SYSTEM THAT HAD THESE ERRORS. WE CALLED IN A BAYER FIELD ENGINEER. HE CHECKED THE SYSTEM AND FOUND NOTHING WRONG. DURING ONE TECH SUPPORT CALL A BAYER TECH MENTIONED THAT A PART IN THE HEAD COULD WEAR AND GIVE SOME PRESSURE ISSUES SO WE DECIDED TO REPLACE THE HEAD. MANUFACTURER RESPONSE FOR DYE INJECTOR, STELLANT (PER SITE REPORTER). REPLACED INJECTOR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214621 MEDRAD STELLANT CT INJECTION SYSTEM INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BAYER MEDICAL CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1