BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM INFUSION SET

    MDR report key: 8810096 · Received July 21, 2019

    Report

    Report Number
    3005053560-2019-00003
    Event Type
    Malfunction
    Date Received
    July 21, 2019
    Report Date
    July 21, 2019
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K050301
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IRADIMED HAS RECEIVED THE PRODUCT FOR EVALUATION, AND THE INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE PRODUCT INVESTIGATION HAS BEEN COMPLETED BY IRADIMED CORPORATION. (B)(4).

    Description of Event or Problem · 1

    DURING AN MRI INFUSION OF LEVOPHED, THE NURSE REPORTED PATIENT CALLED HER INTO THE MR SCANNER ROOM TO INFORM HER THE IV SET BEING USED WAS LEAKING. THE NURSE DESCRIBED THAT THE INFUSION SET HAD A 5 CM TEAR IN THE SILICONE PUMP CHAMBER TUBING. NO INFORMATION WAS PROVIDED AS TO THE SOURCE OF THE TEAR IN THE TUBING. THE INFUSION SET WAS QUICKLY REPLACED TO CONTINUE THE INFUSION. THE PATIENT'S BLOOD PRESSURE INITIALLY DROPPED, BUT RECOVERED WHEN THE INFUSION SET WAS REPLACED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603869 MRIDIUM INFUSION SET INFUSION SET FPA IRADIMED CORPORATION 1056 19A16N

    Patients

    Seq Age Sex Outcome Treatment
    1