MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM 3860+; INFUSION PUMP

Model Number	3860+
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer experienced an event in which the infusion pump delivered a large bolus to the patient at the beginning of the infusion.According to the biomedical engineer, they believed the event was due to user error and requested assistance to download the device history log.The customer confirmed that no patient harm occurred.However, the patient became agitated and required a ventilator.
Additional Manufacturer Narrative
The reported event involved the infusion pump s/n (b)(6) and sidecar s/n (b)(6).The available information does not reasonably suggest that either device (3860+/3861) malfunctioned, as there is no evidence of a malfunction.Specifically, after the initial report, the device history log provided by the customer was reviewed for operational details.The review of the history log (which contains the history of both channel a and its attached channel b) 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, as indicated by error code for (check door possible free-flow alarm) occurring in the pump's history log at the time of the event.This was determined through a thorough investigation that included interviews with the user and review of the device history log.The customer confirmed that no harm occurred to the patient.However, since the reported event resulted in medical intervention by means of placing the patient on a ventilator to preclude or prevent permanent impairment, iradimed is reporting this event.

• Brand Name: MRIDIUM 3860+
• Common Device Name: INFUSION PUMP
• 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: 21129928
• Report Number: 3005053560-2024-00007
• Device Sequence Number: 6807214
• 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): 01/10/2024

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: 12/11/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2023
• 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: Required Intervention
• Patient Sex: Unknown