BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 2837309 · Received October 12, 2012

    Report

    Report Number
    3005053560-2012-00013
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. CUSTOMER IS RETURNING PRODUCT AND THE INFUSION SET TO IRADIMED CORPORATION FOR EXAMINATION. PRODUCT HAS NOT YET BEEN RECEIVED AT IRADIMED CORPORATION. A FOLLOW-UP REPORT WILL BE FILED WITHIN 30 DAYS OF THIS REPORT.

    Description of Event or Problem · 1

    DURING AN MRI INFUSION, ANESTHESIOLOGIST NOTED THE PATIENT'S BLOOD PRESSURE WAS DECREASING. AT THE TIME THE PATIENT, WAS RECEIVING AN INFUSION OF DIPROVAN AT 13 ML/HR. THE INFUSION WAS DISCONTINUED, AND NO INJURY RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3851

    Patients

    Seq Age Sex Outcome Treatment
    1