BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 2845236 · Received October 29, 2012

    Report

    Report Number
    3005053560-2012-00016
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 29, 2012
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN EXAMINED BY IRADIMED CORPORATION. THE HOSPITAL'S EXAMINATION OF THE PUMP INDICATED THE LOWER DOOR HINGE WAS COMPLETELY BROKEN, AND WAS NOT KEEPING THE DOOR FULLY CLOSED. CUSTOMER IS RETURNING PRODUCT 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, THE USER REPORTED AN OVERINFUSION OF NORMAL SALINE TO THE PATIENT. IT IS BELIEVED THE PATIENT RECEIVED APPROXIMATELY 400 ML OF SALINE IN APPROXIMATELY 90 MINUTES. AS THE PATIENT REQUIRED ADDITIONAL FLUID AS PART OF THE THERAPY, THIS EXCESS FLUID WAS ACCOMMODATED WITHOUT ANY PROBLEMS. NO PATIENT INJURY RESULTED FROM THIS EVENT. SUBSEQUENT EXAMINATION OF THE PUMP REVEALED THE PUMP'S LOWER DOOR HINGE HAD BEEN BROKEN PRIOR TO THE INFUSION, AND WAS NOT OBSERVED BY THE USERS.

    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 2 YR MRIDIUM 3850 PUMP (USED WITH THE 3851 PUMP| ASSEMBLY)