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

Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available for evaluation, nor was the device history log provided by the customer.However, during a technical support call on june 6, 2025, the biomed confirmed that on the day of the event, the drug library card had been popped out of the device, preventing the pump from reading the drug library.The user proceeded to program the pump using the dose rate calculator while the infusion pump was operating without a loaded drug library.Instead of selecting propofol, the user chose "drug?" from the dose rate calculator.It is highly probable that the user did not adjust the default concentration of 1 mg/ml to 10 mg/ml, which is the standard concentration for propofol.This discrepancy would result in a 10× faster infusion rate.This finding aligns with the event as reported in the complaint, where the user observed that the infusion was running faster than the intended rate.Therefore, the infusion was administered using "drug?" as the selected drug, and the user inadvertently misprogrammed it.The available information does not indicate that the pump malfunctioned.Additionally, the operation manual includes instructions and explanations for using the dose rate calculator.The most probable root cause of this event is user error in programming the infusion pump.The customer did not provide the patient's outcome but confirmed that the patient required medical intervention to preclude harm via airway support.Therefore, iradimed is reporting this event.
Event or Problem Description
It was reported that the user experienced a possible over-infusion event.According to the biomed, the infusion pump was running normally when they suddenly noticed a question mark on the display, and the pump began infusing at a faster rate, resulting in an over-infusion.According to the nurse manager, the patient did not suffer any harm but was placed on airway support to prevent or preclude potential harm.

• 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: 22386656
• Report Number: 3005053560-2025-00006
• Device Sequence Number: 13030592
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 0100856038001089IR60101382
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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
• 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: 06/05/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2014
• 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
• Patient Weight: 15 KG