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

Model Number	3860+
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Apnea (1720)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 02/15/2023 the hospital biomedical engineer provided additional information that bag ventilation for apnea and laryngeal mask airway were required following the event, but still no further details were available.Therefore, the become aware date is 02/15/2023 when it was reported that medical intervention was necessary due to use of the mridium 3860+ infusion pump.The hospital biomedical engineer provided the history log of the pump on 02/23/2023 and upon analysis of the pump history, it appears the pump operated as programmed.It is unclear due to the limited information from the user if more than one drug was actually used, but the history log shows two seperate infusions first of a muscle relaxer at a very high rate, followed by a sedative for a longer duration.It is possible that the two medications required medical intervention to overcome the patient's apnea.
Event or Problem Description
It was reported that an event occurred, but no other details were initially available.On 02/15/2023 the hospital biomedical engineer provided additional information that bag ventilation for apnea and laryngeal mask airway were required following the event, but still no further details were available.On 02/23/2023 the history log file from the infusion pump was provided for assistance in interpreting the data.The history log shows that on 02/03/2023 the user programmed cisatracurium at a rate of 350 mg/kg/hr for a 7.7 kg patient.The calculated rate for this dose is 1348 ml/hr based on the patient size.The pump was programmed to infuse 23 ml at this rate which should take about 1 minute.The infusion was started, and 51 seconds later the pump stopped with an alarm for patient occlusion.The user reset the alarm and restarted the pump at the same rate.A second patient occlusion occurred and again the user reset the alarm and restarted the pump.A third occlusion alarm occurred and this time the user changed the programming to a new drug, propofol, and a new rate of 150 mcg/kg/min with a dilution of 10 mg/ml for the same 7.7 kg patient.It is unknown if the wrong drug was initially selected and then corrected, or if there were two drugs infused back to back.There was about 3-4 minutes between the two drugs, so it is possible that the medication was changed to match the programming.Because the only details the hospital will share is that an event occurred and the date of the event, the log is the only details available.Cisatracurium is a muscle relaxer, and propofol is an anesthetic and a sedative.Together, it is possible that the doses required medical intervention to overcome the patient's apnea.

• 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: steven kachelmeyer ; 1025 willa springs drive; winter springs, FL 32708 ; 4076778022
• MDR Report Key: 16531629
• Report Number: 3005053560-2023-00001
• Device Sequence Number: 7159767
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 00856038001089
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

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: 02/10/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2013
• 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
• Patient Weight: 8 KG