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

Model Number	3860+
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	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history log for (b)(6) 2025, the day of the event, indicates the user programmed the pump using the dose rate calculator while the infusion pump was operating without a drug library.Instead of selecting propofol, the user chose "drug?" from the dose rate calculator.The user never adjusted the default concentration of 1 mg/1 ml to 10 mg/1 ml, which is the standard propofol concentration.This discrepancy would result in a 10x faster infusion rate.This finding aligns with the event as reported in the complaint, where the intended infusion rate was 13.0 ml/hr., but the logged rate was 130 ml/hr.Therefore, the infusion was run using "drug?" as the drug of choice, 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 calculator.The most probable root cause of this event is user error programming the infusion pump.The customer did not provide the outcome of the patient but confirmed that the patient required medical intervention to preclude harm; therefore, iradimed is reporting this event.
Event or Problem Description
It was reported that the customer experienced a potential over-infusion event.According to biomed, the intended infusion rate was 13.0 ml/hr; however, the infusion rate during the event was 130 ml/hr.The user stated that they were using the drug library and had selected propofol.Biomed inspected the pump and could not reproduce the increased rate using the drug library, but upon reviewing the log, he noticed that the user had selected "drug ?".Biomed wanted to confirm this finding by evaluating the history log, as user error was suspected.The patient's status was described as having "crashed during the event" and required medical intervention to preclude 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
• MDR Report Key: 22107378
• Report Number: 3005056560-2025-00004
• Device Sequence Number: 8233092
• 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): 05/29/2025

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: 04/29/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2013
• 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: Required Intervention
• Patient Sex: Unknown