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

Model Number	3860+
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Iradimed evaluated the provided images and observed that a green "mri safe" sticker had been placed on the base of a non-iradimed iv pole.Iradimed reached out to biomed, who confirmed that no patient was involved during the event and acknowledged that the incident resulted from user error, as a non-iradimed magnetic pole was provided to the user.This caused both the pole and the infusion pump to be attracted to the magnet.The customer's personnel have since been trained and instructed never to remove the pump from the "mri safe" iradimed pole.According to the customer, moving forward, they will keep both the pump and the monitor on the same pole to streamline their workflow.The non-mri safe pole involved in the event was a non-iradimed pole and therefore not manufactured by iradimed.However, since an iradimed infusion pump was attached to it and a clinical staff member was harmed, iradimed is reporting this event.
Event or Problem Description
It was reported that the customer experienced an event in the icu where the iradimed pole was too large for their elevators, and they had to remove the iradimed infusion pump to transport it down to the mri.Upon arriving at the mri, they were provided with a non-mri safe pole that was not an iradimed pole.This pole was pulled into the magnet, resulting in an mri staff member's arm being broken.

• 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 ; 4076778022
• MDR Report Key: 20375199
• Report Number: 3005053560-2024-00005
• Device Sequence Number: 3796131
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 0100856038001089
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 10/04/2024

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: 09/04/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown