BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 2764467 · Received September 25, 2012

    Report

    Report Number
    3005053560-2012-00009
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    August 21, 2012
    Report Date
    September 22, 2012
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT YET BEEN EXAMINED BY IRADIMED CORPORATION. PRODUCT IS BEING RETURNED TO IRADIMED FOR EXAMINATION, WHICH HAS NOT YET OCCURRED. THE INFUSION SET USED AT THE TIME OF THE EVENT WAS DISCARDED BY THE HOSPITAL. THIS IS THE SECOND REPORT FROM THE SAME HOSPITAL IN LESS THAN 1 MONTH OF A SIMILAR EVENT. THIS CUSTOMER HAS RECENTLY BEGUN USING THE PRODUCT, AND THIS EVENT INVOLVED THE SAME NURSE AS IN THE FIRST EVENT. F/U TRAINING HAS BEEN PERFORMED AT THIS CUSTOMER SITE SINCE THIS EVENT. INVESTIGATION IS STILL IN PROCESS. A F/U REPORT WILL BE FILED WITHIN 30 DAYS OF THIS REPORT.

    Description of Event or Problem · 1

    DURING SETTING UP THE INFUSION PUMP FOR AN MRI INFUSION, THE NURSE OBSERVED A FREE-FLOW CONDITION WITH THE INFUSION LINE, AND DISCONTINUED USE OF THE PUMP. NO PT WAS INVOLVED WITH THIS EVENT, AS THE INFUSION WAS NOT STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3860+

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention