MAUDE Adverse Event Report: Iradimed Corporation MRiduim 3860 Series MRI Infusion Pump/Monitor System; Pump, Infusion

Model Number	3860+
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer experienced an event in which the infusion pump shut down during patient transport.According to the biomedical engineering technician, while the patient was being transported into an elevator, the pump displayed alarm codes 129 and 229.At the time of the initial report, no patient harm or serious injury was reported, and no medical intervention to prevent or preclude harm was reported.
Additional Manufacturer Narrative
The event was initially reported by the facility's biomedical engineering technician to iradimed's clinical application specialist on july 6, 2026.The complaint was subsequently escalated internally to iradimed regulatory affairs on july 7, 2026.During a follow-up telephone conversation with the customer on (b)(6) 2026, it was reported that the infusion pump shut down during patient transport.According to the biomedical engineering technician, while the patient was being transported into an elevator, the pump displayed alarm codes 129 and 229.At that time, no patient harm or medical intervention was reported.Following the initial communication, iradimed performed due diligence to obtain additional information regarding the circumstances of the event and the patient's status and outcome.Follow-up efforts included telephone communications on august 7, 2026, and august 23, 2026, as well as email correspondence sent on august 21, 2026, requesting additional event details and information regarding the patient's status and outcome.The customer did not respond to the august 21, 2026 email requesting this additional information.During a follow-up telephone conversation with the biomedical engineering technician on august 23, 2026, iradimed was informed that the infusion pump involved in the event, serial number (b)(6), could not be returned to iradimed for evaluation because the event involved a patient who reportedly coded and the event was under the facility's internal investigation.The customer did not provide further information regarding the circumstances surrounding the reported coding event, the patient's clinical outcome, or whether medical intervention was required.Through the august 23, 2026 communication, iradimed first became aware that the event involved a patient who the customer reported "coded." the customer did not provide additional information regarding the patient's outcome or whether medical intervention was required.Based on the information available and the clinical awareness date, iradimed determined that the event should be reported under the medical device reporting requirements.Iradimed's investigation is ongoing.Despite multiple due diligence attempts, additional information regarding the circumstances of the event, the patient's clinical outcome, medical intervention, and the relationship, if any, between the device and the reported patient event has not been provided by the customer.The device has not been returned to iradimed for evaluation; therefore, a physical evaluation of the device has not been performed.Iradimed is submitting this initial mdr based on the information currently available and the additional information received on august 23, 2026.A supplemental report will be submitted if additional reportable information becomes available, including additional information regarding the patient outcome, device evaluation, or investigation findings.

• Brand Name: MRiduim 3860 Series MRI Infusion Pump/Monitor System
• Common Device Name: Pump, Infusion
• Manufacturer (Section D): Iradimed Corporation; 12705 ingenuity dr; orlando FL 32826
• Manufacturer (Section G): Iradimed Corporation; 12705 ingenuity dr; orlando FL 32826
• Manufacturer Contact: leonardo aldarondo ; 12705 ingenuity dr; orlando, FL 32826 ; +1(407)677-8022
• MDR Report Key: 50863204
• Report Number: 3005053560-2026-00003
• Device Sequence Number: 9314406
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 010085603800108921IR60105978
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3860+
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown