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	Insufficient Information (4580)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event involved the infusion pump s/n (b)(6).The available information does not reasonably suggest that the device (3860+) malfunctioned, as there is no evidence of a malfunction.Specifically, after the initial report, the device history log was reviewed for operational details.The review of the history log (which contains the history of both channel a found that error for (check door possible free-flow) occurred at the time of the event, demonstrating that the device activated its high-priority audible and visual "check door" possible free-flow alarm as designed.This indicates that the possible over-infusion was caused by user error when installing the iv set, likely caused by the user pushing in the free-flow preventer clamp when installing the set.The most probable root cause for the events reported above is user error due to improper installation of an iv set.This was indicated by an error code for a 'check door possible free-flow alarm' in the pump's history log at the time of the event, which documented a possible free-flow event or over-infusion.This determination was made through a thorough investigation that included interviews with the user and a review of the device history log.The customer confirmed that the patient suffered harm or required medical intervention to preclude or prevent harm.Iradimed has made several due diligence efforts to gather additional information about the patient's outcome; however, the customer has not provided any further details.Since the available information suggests that the patient required medical intervention, iradimed is reporting this event.
Event or Problem Description
It was reported that the customer experienced a possible over-infusion event.According to biomed, the pump was programmed with a vtbi of 77.6 ml.However, the user noticed that a few minutes after starting the infusion, the volume left in the reservoir was 32.3 ml.Biomed inspected the infusion pump and observed that the pump indicated only 2.2 ml had been infused.It was reported that the patient suffered harm, but no additional information was provided.

• 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: 22301533
• Report Number: 3005053560-2025-00005
• Device Sequence Number: 21042066
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 0100856038001089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2016
• 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