BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRIDIUM 3860+

    MDR report key: 20792938 · Received November 27, 2024

    Report

    Report Number
    3005053560-2024-00006
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    September 17, 2024
    Report Date
    November 26, 2024
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K143369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCTOBER 28, 2024, THE FDA NOTIFIED IRADIMED CORPORATION OF AN ADVERSE EVENT THAT OCCURRED ON SEPTEMBER 17, 2024. THE EVENT WAS EVALUATED, AND IT WAS DETERMINED THAT THE PATIENT REQUIRED MEDICAL INTERVENTION TO PRECLUDE HARM AND IS THEREFORE BEING REPORTED AT THIS TIME. THIS EVENT INVOLVED AN INFUSION PUMP 3860+, BUT THE SERIAL NUMBER WAS NOT PROVIDED. FOLLOWING THE INITIAL REPORT, IRADIMED INITIATED DUE DILIGENCE EFFORTS TO GATHER ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER HAS NOT RESPONDED TO THESE EFFORTS. THEREFORE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF THE USER PROVIDES ADDITIONAL DETAILS DURING THE INVESTIGATION, AN MDR SUPPLEMENT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON OCTOBER 28, 2024, THE FDA NOTIFIED IRADIMED CORPORATION OF AN ADVERSE EVENT THAT OCCURRED ON (B)(6) 2024. THE CUSTOMER REPORTED THE FOLLOWING EVENT: AN OUTPATIENT CAME TO THE MRI FOR AN EXAM TO BE PERFORMED UNDER ANESTHESIA. THE PATIENT WAS HOOKED UP TO MONITORING EQUIPMENT, AND THE ANESTHESIOLOGIST PROGRAMMED THE MRI PUMP TO DELIVER PROPOFOL DURING THE EXAM. THE TUBING WAS THEN ATTACHED TO THE PATIENT TO ADMINISTER THE MEDICATION. THE PATIENT WAS TRANSFERRED INTO THE MRI ROOM, AND THE TEAM BEGAN POSITIONING THE PATIENT FOR THE EXAM. WHILE POSITIONING THE PATIENT, PRIOR TO BEGINNING THE EXAM, THE TWO DOCTORS BECAME CONCERNED WITH THE PATIENT'S CHANGING VITAL SIGNS. THE PATIENT RAPIDLY BECAME UNSTABLE. THE DOCTORS STATED THAT THE PATIENT WAS PULSELESS AND CALLED A CODE BLUE. DOCTORS BEGAN CHEST COMPRESSIONS, RESCUE BREATHS, AND LIFE-SAVING TECHNIQUES. EVENTUALLY, A PULSE WAS RE-OBTAINED. WHILE INVESTIGATING THE INCIDENT, IT WAS IDENTIFIED THAT THE MRI INFUSION PUMP ADMINISTERED THE ENTIRE AMOUNT OF PROPOFOL INSTEAD OF THE PROGRAMMED AMOUNT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843434 MRIDIUM 3860+ INFUSION, PUMP FRN IRADIMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| L