MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDUIM 3860 SERIES MRI INFUSION PUMP/MONITOR SYSTEM; Pump, infusion

Model Number	3860+
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an mri scan, the accompanying nurse noticed that the new bottle of propofol had completely emptied when it was connected to the patient's central line, even though the pump appeared to be working properly (green light and flow rate between 5 and 7 cc/h).The patient therefore received the entire bottle of propofol (1000 mg).
Additional Manufacturer Narrative
The event was first reported to our international sales and clinical representatives by the importer, c.H.S., ltd.The complaint was then escalated internally to iradimed regulatory affairs.Iradimed has conducted due diligence to gather more information.Our investigation has included the following: phone calls: iradimed contacted c.H.S., ltd.By phone on august 13, 2025.Contact was established and an investigation was initiated to gather additional information through an interview.Email correspondence: an email requesting additional details was sent to c.H.S., ltd.On august 13, 2025.Additionally, on august 19, 2025, an email was sent to inform c.H.S., ltd.Of the reportability of this event, and a copy of the report was provided.After several due diligence attempts, the distributor provided the device history log on september 5, 2025.Iradimed evaluated the provided device history log for device ir60106062 from august 6, 2025, to august 8, 2025.The most significant entry in the history log is a "check door-freeflow" code, which indicates potential issues with how the infusion set was loaded.This may suggest that the user did not properly press the black flow-stop clamp inward until it was seated.This situation can only occur if the door is open and the flow-stop clamp is fully inserted into the pump immediately after it is powered on.This opens the clamp and allows momentary free-flow while the door is open.This pattern repeated twice in the log.Since the pump does not record when the door is closed, it raises the possibility that the pump may have inadvertently been allowed to free-flow during these intervals if the door remained open.The most probable root cause of this event is user error in loading or installing the iv set.The history log documented a possible over-infusion, showing user error when loading the infusion set.Refresher training will be made available to the customer to reinforce proper iv set setup and priming procedures.

• Brand Name: MRIDUIM 3860 SERIES MRI INFUSION PUMP/MONITOR SYSTEM
• Common Device Name: Pump, infusion
• Manufacturer (Section D): IRADIMED CORPORATION; 1025 willa springs drive; winter springs FL 32708
• Manufacturer (Section G): IRADIMED CORPORATION; 1025 willa springs drive; winter springs FL 32708
• Manufacturer Contact: leonardo aldarondo ; 1025 willa springs drive; winter springs, FL 32708 ; 4076778022
• MDR Report Key: 23042329
• Report Number: 3005053560-2025-00009
• Device Sequence Number: 18655449
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 0100856038001089
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• 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