BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRIDIUM 3860G PLUS

    MDR report key: 23446067 · Received November 3, 2025

    Report

    Report Number
    3005053560-2025-00012
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    September 30, 2025
    Report Date
    November 1, 2025
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    UDI-DI
    00856038001089
    PMA / PMN Number
    K143369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE AND EVENT WERE EVALUATED BY THE DISTRIBUTOR AND BY REVIEWING THE VIDEO PROVIDED BY THE CUSTOMER. THE DISTRIBUTOR QUALITY REPRESENTATIVE SUCCESSFULLY REPRODUCED THE EVENT WITH THE 3860+ MULTIPLE TIMES, UTILIZING THE CORRESPONDING RUN TIMES AND FLOW RATES. IT IS HIGHLY PROBABLE THAT THE USER'S OBSERVED SWITCHING OF THE 3860+ FROM THE PROGRAMMED RATE TO A FLOW RATE OF 1 ML/HR CORRESPONDS TO THE KEEP VEIN OPEN (KVO) MODE AND OPERATED AS DESIGNED. KVO MODE IS AUTOMATICALLY ACTIVATED WHEN THE PROGRAMMED INFUSION VOLUME TO BE INFUSED (VTBI) REACHES 0 ML. IN THIS SCENARIO, THE PUMP SWITCHED TO THE DEFAULT KVO RATE, WHICH IS 1.0 ML/HR. THE PATIENT HAD PRE-EXISTING CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE OUTCOME. HOWEVER, DETAILS REGARDING THE NECESSITY OF MEDICAL INTERVENTION HAVE NOT YET BEEN PROVIDED. SINCE THE EVENT INVOLVED A SUDDEN DROP IN PATIENT BLOOD PRESSURE AND THE REQUIREMENT FOR MEDICAL INTERVENTION TO PREVENT HARM REMAINS UNCLARIFIED, IRADIMED IS REPORTING THIS EVENT UNDER MDR 30005053560-2025-00012.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE CUSTOMER EXPERIENCED AN EVENT INVOLVING TWO IRADIMED MRIDIUM INFUSION PUMPS (SAEGELING), SERIAL NUMBERS (B)(6). THE PATIENT, WHO HAD SUFFERED MULTIPLE GENERALIZED SEIZURES DURING THE RECOVERY PHASE, REQUIRED A HEAD MRI. DURING THE EXAMINATION, THE PATIENT WAS SEDATED WITH PROPOFOL ADMINISTERED VIA AN MRIDIUM SYRINGE PUMP (S/N (B)(6)), AND BLOOD PRESSURE WAS SUPPORTED WITH NOREPINEPHRINE VIA A SECOND SYRINGE PUMP OF THE SAME BRAND (S/N (B)(6)). THE NOREPINEPHRINE PUMP WAS SET TO A DOSE OF G/KG/MIN, AND THE PROPOFOL PUMP WAS SET TO MG/KG/H. ARTERIAL BLOOD PRESSURE, HEART RATE, OXYGEN SATURATION (O2), AND END-TIDAL CO2 WERE CONTINUOUSLY MONITORED, WITH THE MONITORING DISPLAYED IN THE MRI CONTROL ROOM. THE PATIENT INITIALLY HAD STABLE HEMODYNAMIC CONDITIONS, AND ANESTHESIA WAS MONITORED REMOTELY FROM THE CONTROL ROOM. DURING THE EXAMINATION, A SUDDEN DROP IN BLOOD PRESSURE OCCURRED. UPON IMMEDIATE ASSESSMENT, IT WAS DISCOVERED THAT THE NOREPINEPHRINE PUMP HAD AUTOMATICALLY CHANGED THE DOSE SETTING FROM 0.06 ¿G/KG/MIN TO 1 ML/H WITHOUT USER INTERVENTION. AT THE END OF THE EXAMINATION, THE PROPOFOL PUMP ALSO AUTOMATICALLY CHANGED ITS DOSING SETTING FROM 5 MG/KG/H TO 1 ML/H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709152 MRIDIUM 3860G PLUS Pump, infusion FRN IRADIMED CORPORATION 3860+ 00856038001089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other S/N: (B)(6).UDI: (B)(4).