MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM 3860G PLUS; Pump, infusion

Model Number	3860+
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device and event were evaluated by the distributor and by reviewing the video provided by the customer.The distributor quality representative successfully reproduced the event with the 3860+ multiple times, utilizing the corresponding run times and flow rates.It is highly probable that the user's observed switching of the 3860+ from the programmed rate to a flow rate of 1 ml/hr corresponds to the keep vein open (kvo) mode and operated as designed.Kvo mode is automatically activated when the programmed infusion volume to be infused (vtbi) reaches 0 ml.In this scenario, the pump switched to the default kvo rate, which is 1.0 ml/hr.The patient had pre-existing conditions that may have contributed to the outcome.However, details regarding the necessity of medical intervention have not yet been provided.Since the event involved a sudden drop in patient blood pressure and the requirement for medical intervention to prevent harm remains unclarified, iradimed is reporting this event under mdr 30005053560-2025-00012.
Event or Problem Description
It was reported by the distributor that the customer experienced an event involving two iradimed mridium infusion pumps (saegeling), serial numbers (b)(6).The patient, who had suffered multiple generalized seizures during the recovery phase, required a head mri.During the examination, the patient was sedated with propofol administered via an mridium syringe pump (s/n (b)(6)), and blood pressure was supported with norepinephrine via a second syringe pump of the same brand (s/n (b)(6)).The norepinephrine pump was set to a dose of g/kg/min, and the propofol pump was set to mg/kg/h.Arterial blood pressure, heart rate, oxygen saturation (o2), and end-tidal co2 were continuously monitored, with the monitoring displayed in the mri control room.The patient initially had stable hemodynamic conditions, and anesthesia was monitored remotely from the control room.During the examination, a sudden drop in blood pressure occurred.Upon immediate assessment, it was discovered that the norepinephrine pump had automatically changed the dose setting from 0.06 ¿g/kg/min to 1 ml/h without user intervention.At the end of the examination, the propofol pump also automatically changed its dosing setting from 5 mg/kg/h to 1 ml/h.

• Brand Name: MRIDIUM 3860G PLUS
• 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 ; 4076778022
• MDR Report Key: 23446067
• Report Number: 3005053560-2025-00012
• Device Sequence Number: 8960954
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 0100856038001089
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2025

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+
• Device Catalogue 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: 10/02/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: S/N: (B)(6).UDI: (B)(4).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown