BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD CONTINUUM MR INFUSION SYSTEM SECONDARY ADMINISTRATION

    MDR report key: 1316936 · Received February 12, 2009

    Report

    Report Number
    1316936
    Event Type
    Malfunction
    Date Received
    February 12, 2009
    Date of Event
    February 10, 2009
    Report Date
    February 12, 2009
    Manufacturer
    MEDRAD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    IV TUBING WAS PLACED IN AN INFUSION PUMP FOR USE DURING AN MR (MAGNETIC RESONANCE) PROCEDURE. THE NURSE OBSERVED BLOOD BACKING UP IN THE TUBING, AND THE SEALED AREA ON THE TUBING SET WAS APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD CONTINUUM MR INFUSION SYSTEM SECONDARY ADMINISTRATION TUBING, IV FPA MEDRAD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR