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	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event involved the infusion pump s/n (b)(6).The available information does not reasonably suggest that the device 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 history log indicated user error when loading the infusion set, logging a "check door-freeflow" alarm, and documenting a possible over-infusion of heparin.The most probable root cause of this event is user error in loading the infusion set.The customer reported that the patient had a preexisting condition, being treated for a hepatic abscess and pe, which may have contributed to the attp values reported.The customer confirmed that no evident or serious harm occurred to the patient.However, since the reported event resulted in medical intervention by means of medication adjustments to preclude or prevent permanent impairment, iradimed is reporting this event.
Event or Problem Description
It was reported that the customer experienced an event in which the rn programmed the mri-compatible pump with dual rn sign-off.The patient was taken to mri, where a new bag of heparin was started at 22:06, also with dual rn sign-off using the mri-compatible pump.The patient remained in mri and was brought back to the floor at 22:50.The rn noticed that the new bag of heparin was less than half full after only running for one hour.The rn paused the infusion, and a ptt was drawn.The pump was supposed to deliver 40.55 ml/hr, but it appears the patient received approximately 250 ml within 50 minutes.Although the facility confirmed that no obvious harm was noted from the event, they did report that medical intervention was required to preclude harm.

• 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: 20305057
• Report Number: 3005053560-2024-00004
• Device Sequence Number: 7791589
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 0100856038001089
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male