BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MPAT

    MDR report key: 2871324 · Received October 24, 2012

    Report

    Report Number
    2871324
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDRAD INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    DURING SETUP OF A NEW MULTI-PATIENT DISPOSABLE SET, THE CONTRAST PORTION OF THE TUBING KINKED AT TUBING/DRIP CHAMBER PORTION AND WAS NOT ALLOWING CONTRAST TO BE INJECTED. STAFF ATTEMPTED TO UNKINK TUBING AND WAS UNSUCCESSFULL SO A NEW SET WAS SET UP AND USED. IT WORKED JUST FINE. NO PATIENT WAS INVOLVED. ======================MANUFACTURER RESPONSE FOR FLUID MANAGEMENT SYSTEM, AVANTA (PER SITE REPORTER).======================UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA MPAT MULTI-PATIENT DISPOSABLE KIT DXT MEDRAD INC. * 120601

    Patients

    Seq Age Sex Outcome Treatment
    1 *