MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM; INFUSION PUMP

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient experienced a potential under-infusion event.According to biomed, the mri technician observed a bubble of air in the iv line.However, no additional information was provided regarding whether any alarms occurred during the event.Per biomed the patient coded during the event.
Additional Manufacturer Narrative
The device history log suggested that the user likely had issues priming the iv set line.A "bubble detector activity" was logged, indicating that the bubble detector was active and detected a bubble below the alarm threshold immediately after the infusion started.Subsequently, a "bubble detected" alarm occurred shortly after the infusion began.This was consistent with the event description provided by the biomed, where the user observed air in the iv set when the "bubble detected" alarm was triggered.The presence of the "bubble detected" alarm, occurring after the infusion parameters were set and immediately after the infusion began, strongly indicated that air was present in the iv line at the start of the infusion.Proper priming of the iv set is crucial to remove all air from the tubing before connecting it to the patient and initiating the infusion.The operator's manual and the iv set pouch label contained instructions on how to properly prime the iv set.The device history log showed that the user opened the door after the bubble alarm, potentially attempting to troubleshoot the issue.All alarms were silenced by the user before the infusion was canceled.A bubble alarm in this context is a common sign that the priming step may have been insufficient, missed, or that the user experienced difficulty priming and setting up the line.This could have led to air being detected by the pump and may have resulted in a delay of therapy.The customer confirmed that the patient coded during the event and that medical intervention was required.Therefore, iradimed is reporting this event.

• Brand Name: MRIDIUM
• 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: 22031137
• Report Number: 3005053560-2025-00003
• Device Sequence Number: 12790223
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 0100856038001089
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/15/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2016
• 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: Death
• Patient Sex: Unknown