BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM 3860+ INFUSION PUMP

    MDR report key: 5197254 · Received October 29, 2015

    Report

    Report Number
    3005053560-2015-00011
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    September 21, 2015
    Report Date
    October 26, 2015
    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

    THE PRODUCT IS BEING RETURNED TO IRADIMED CORPORATION FOR EXAMINATION. A FOLLOW-UP REPORT WILL BE PROVIDED WITHIN 45 DAYS FOLLOWING EXAMINATION OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2015 A NURSE REPORTED THAT DURING A PATIENT INFUSION IN THE MRI, THE PATIENT MAY HAVE RECEIVED AN EXCESS VOLUME OF FLUID CONTAINER HYPERTONIC SALINE SOLUTION DURING THE INFUSION. THE PATIENT STATUS WAS NOT REPORTED AT THIS TIME. FOR ANY FURTHER INFORMATION, SHE REFERRED THE MANUFACTURER TO THE RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL, WHICH RESULTED IN DISCUSSION WITH THE HOSPITAL'S BIOMEDICAL ENGINEERING MANAGER, WHO REQUESTED HELP REVIEWING THE PUMP'S EVENT LOG. NO DETAILS OF THE EVENT WERE PROVIDED AT THIS TIME. INFORMATION TO PROVIDE THE EVENT LOG WERE PROVIDED ON (B)(6). FOLLOW-UP CONTACT ON (B)(6) RESULTED IN CONFIRMED THAT, FROM THE PUMP'S EVENT LOG REVIEW, THE PUMP HAD BEEN PROGRAMMED PROPERLY, AND THE HOSPITAL REQUESTED AN EXAMINATION OF THE PRODUCT BY IRADIMED CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720387 MRIDIUM 3860+ INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3860+

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention