BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRIDUIM 3860 SERIES MRI INFUSION PUMP/MONITOR SYSTEM

    MDR report key: 22765423 · Received August 8, 2025

    Report

    Report Number
    3005053560-2025-00007
    Event Type
    Death
    Date Received
    August 8, 2025
    Date of Event
    July 8, 2025
    Report Date
    August 8, 2025
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K143369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS FIRST REPORTED BY THE DIRECTOR OF RADIOLOGY AND IMAGING AT THE FACILITY TO OUR LOCAL SALES REPRESENTATIVE. THE COMPLAINT WAS THEN ESCALATED INTERNALLY TO IRADIMED REGULATORY AFFAIRS. IRADIMED HAS PERFORMED DUE DILIGENCE TO GATHER MORE INFORMATION. OUR INVESTIGATION HAS INCLUDED: PHONE CALLS: ATTEMPTS WERE MADE TO CONTACT (B)(6), THE DIRECTOR OF RADIOLOGY AND IMAGING, ON (B)(6) 2025, BUT NO CONTACT WAS ESTABLISHED. EMAIL CORRESPONDENCE: AN EMAIL REQUESTING ADDITIONAL DETAILS WAS SENT ON JULY 11, 2025, TO THIS SAME DIRECTOR, WHICH RECEIVED NO RESPONSE. ON-SITE VISIT: ON JULY 28, 2025, IRADIMED SALES PERSONNEL MET WITH THE VICE PRESIDENT OF OPERATIONS, THE MRI MANAGER, AND THE CHIEF OF ANESTHESIA AT (B)(6) TO GATHER MORE DETAILS. HOWEVER, NO FURTHER DETAILS OF THIS INCIDENT WERE PROVIDED. THIS INVESTIGATION IS ONGOING. DESPITE SEVERAL DUE DILIGENCE ATTEMPTS TO OBTAIN THE DEVICE INFORMATION, SERIAL NUMBERS, OR HISTORY LOGS, THE CUSTOMER HAS MADE NO RESPONSE. HOWEVER, IRADIMED IS FILING THIS INITIAL REPORT BECAUSE THE EVENT INVOLVED A PATIENT DEATH. A SUPPLEMENT TO THIS REPORT WILL BE SUBMITTED UPON THE CONCLUSION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A POSSIBLE UNDER-INFUSION EVENT. ON JULY 10, 2025, IRADIMED'S QUALITY MANAGER RECEIVED INFORMATION FROM AN IRADIMED SALES REPRESENTATIVE THAT THE DIRECTOR OF RADIOLOGY AND IMAGING AT (B)(6) HOSPITAL REPORTED THAT AN IRADIMED 3860 INFUSION PUMP SHUT OFF DURING AN ACTIVE INFUSION AND THAT A PATIENT CODED IN THE MRI. THE DIRECTOR FURTHER REPORTED THAT THE PATIENT WAS INITIALLY REVIVED BUT SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964560 MRIDUIM 3860 SERIES MRI INFUSION PUMP/MONITOR SYSTEM Pump, infusion FRN IRADIMED CORPORATION 3860+

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death