BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRIDUIM 3860 SERIES MRI INFUSION PUMP/MONITOR SYSTEM

    MDR report key: 24657954 · Received March 21, 2026

    Report

    Report Number
    3005053560-2026-00001
    Event Type
    Death
    Date Received
    March 21, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 20, 2026
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K143369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS INITIALLY REPORTED TO THE LOCAL IRADIMED SALES AND CLINICAL REPRESENTATIVES BY THE MANAGER OF MEDICAL IMAGING AT THE FACILITY AND WAS SUBSEQUENTLY ESCALATED TO IRADIMED REGULATORY AFFAIRS. ON 01/26/2026, AN EMAIL WAS RECEIVED REQUESTING ASSISTANCE REGARDING AN EVENT INVOLVING AN IRADIMED 3860+ MRI INFUSION PUMP. ACCORDING TO FACILITY STAFF, DURING THE SETUP OF A NOREPINEPHRINE INFUSION, THE PUMP DISPLAYED A "CHECK DOOR" OR "DOOR FAILURE" ERROR MESSAGE. UPON ASSESSMENT, IT WAS DISCOVERED THAT THE NOREPINEPHRINE HAD BEEN INFUSING BY GRAVITY FOR APPROXIMATELY 30 SECONDS. THE PATIENT WAS IMMEDIATELY DISCONNECTED FROM THE MEDICATION. IRADIMED HAS PERFORMED EXTENSIVE DUE DILIGENCE TO GATHER ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER HAS NOT YET PROVIDED THE REQUESTED DATA OR RESPONDED TO COMMUNICATIONS. THE FOLLOWING ATTEMPTS TO OBTAIN INFORMATION HAVE BEEN DOCUMENTED: ON JANUARY 26, 2026: INITIAL EMAIL EXCHANGE BETWEEN THE IRADIMED SALES REPRESENTATIVE AND THE MANAGER OF (B)(6). ON JANUARY 26, 2026: IRADIMED ATTEMPTED TO CONTACT THE MANAGER OF MEDICAL IMAGING VIA TELEPHONE; NO CONTACT WAS ESTABLISHED. ON (B)(6) 2026: EMAIL CORRESPONDENCE WAS SENT TO THE MANAGER OF MEDICAL IMAGING REQUESTING THE DEVICE SERIAL NUMBER, HISTORY LOGS, AND PATIENT OUTCOME DETAILS. NO RESPONSE WAS RECEIVED. ON FEBRUARY 23, 2026: IRADIMED RECEIVED TWO MEDWATCH REPORTS FROM THE FDA (MW5184080 AND MW5184086) CONCERNING THIS INCIDENT, WHICH ALLEGED A PATIENT DEATH. ON MARCH 06, 2026: FOLLOW-UP EMAIL CORRESPONDENCE WAS SENT TO THE MANAGER OF MEDICAL IMAGING REQUESTING ADDITIONAL DETAILS. NO RESPONSE WAS RECEIVED. ON MARCH 20, 2026: FOLLOW-UP TELEPHONE CALL WAS ATTEMPTED TO THE MANAGER OF MEDICAL IMAGING; NO CONTACT WAS ESTABLISHED. AT THE TIME OF THIS REPORT, THE SPECIFIC DEVICE SERIAL NUMBER AND HISTORY LOGS HAVE NOT BEEN PROVIDED BY THE FACILITY. THIS INVESTIGATION REMAINS ONGOING. DESPITE MULTIPLE ATTEMPTS TO OBTAIN DEVICE IDENTIFICATION AND HISTORY LOGS, THE FACILITY HAS NOT RESPONDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE CONCLUSION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A POSSIBLE DELAYED THERAPY. ON 01/26/2026, AN EMAIL WAS RECEIVED BY LOCAL IRADIMED SALES AND CLINICAL REPRESENTATIVES FROM THE MANAGER OF MEDICAL IMAGING AT THE FACILITY REQUESTING ASSISTANCE REGARDING AN EVENT INVOLVING AN IRADIMED 3860+ MRI INFUSION PUMP. ACCORDING TO FACILITY STAFF, DURING THE SETUP OF A NOREPINEPHRINE INFUSION, THE PUMP DISPLAYED A "CHECK DOOR" POSSIBLE FREE-FLOW ERROR MESSAGE. UPON ASSESSMENT, IT WAS DISCOVERED THAT THE NOREPINEPHRINE HAD BEEN INFUSING BY GRAVITY FOR APPROXIMATELY 30 SECONDS. THE PATIENT WAS IMMEDIATELY DISCONNECTED FROM THE MEDICATION. NO PATIENT HARM NOR MEDICAL INTERVENTION WERE INITIALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718363 MRIDUIM 3860 SERIES MRI INFUSION PUMP/MONITOR SYSTEM Pump, infusion FRN IRADIMED CORPORATION 3860+

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death