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

Model Number	3860+
Health Effect - Clinical Codes	Bradycardia (1751); Hypoxia (1918); Cognitive Changes (2551)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Iradimed mridium 3860+ iv (intravenous) pump was used to administer continuous infusion of dexmedetomidine during mri (magnetic resonance imaging) scan.During the mri (magnetic resonance imaging) scan patient condition changed.Bradycardia, hypoxia, and mental status changes occurred.Heart rate was 60 bpm, oxygen saturation 80% and glasgow coma score of 6 (baseline gcs 13) rass (richmond agitation-sedation scale) of -5.Dexmedetomidine iv bag had 59 ml of medication unaccounted for that was presumed to have been inadvertently administered to the patient as a pump "over infusion".Pump event log was reviewed by med safety and biomedical engineering staff with assistance of iradimed vice president of quality and regulatory (b)(4).Event log indicates a period where free flow of medication was likely.Examination of the iv pump in question found no abnormalities when subjected to a preventive maintenance inspection by biomed staff.Further analysis and recreation of the circumstances of the event in question revealed several concerns and failure modes, not likely to be identified by users.In some cases, the warnings or alerts presented by the device do not reflect the cause of the failure or critical nature of the condition that is present.Observations the device is a peristaltic infusion pump which depends on the pump door being fully closed to prevent flow.There are 2 flow preventer mechanisms to prevent gravity flow when the door is opened.A black clamp that operates in concert with the door and a independent roller clamp.The black colored flow preventer clamp is supposed to prevent flow every time the door is opened.However, the material the clamp is made of, and its designed mode of operation make it susceptible to failure.The mechanism by which this clamp engages the door are triangle shaped "wings".If the "wings" are displaced by any physical contact, they are inelastic and will subsequently fail to fully engage the door and when the door is opened, and the clamp will not prevent free flow of medication.This failed condition is not obvious to the user.The material being inelastic is essentially single use, single operation as every time the door is opened, the wings are displaced and each additional time the door is opened (to resolve a bubble for example) the clamp can fail to engage and free flow of medication can occur.Unfortunately, the user is required to touch and manipulate this clamp twice with their hands as part of the pump setup process, to prime the tubing.It is difficult to grip and perform these manipulations without displacing the critical wings.Lastly, to insert the tubing into the pump after priming, the wings are vulnerable to contact by the user as the tubing is "snapped" into place.The additional roller clamp provided for use as redundant flow preventer is exceedingly difficult to operate.The force required to position the roller to prevent flow is surprisingly high.Flow was observed after the roller clamp was believed to be adequately tightened by multiple users during experimentation.Two hands and a very high level of force are needed to move the roller clamp to the complete limits of travel to prevent flow.The pump door can appear shut, and the pump can operate, yet the door is not completely latched.Door is made of multiple parts; each part has separate latch that "clicks" shut and both must be latched to prevent flow.The pump can operate without alarms in this partially closed state.The warning text the pump displays in response to potential free flow conditions caused by problem with the door or the black free flow preventer do not reflect critical nature of the alert.Example - alert text reads "check door" after user opens door to resolve a bubble.Users silence this alarm because they intentionally opened the door.However, conditions that cause this door open alert to display are black flow preventer positioned to allow free flow of fluid while door opened ie flow preventer clamp failed to engage when door opened.This is a dangerous condition that is not appropriately reflected by the warning text.

• Brand Name: IRADIMED MRIDIUM 3860+ MRI PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): IRADIMED CORPORATION
• MDR Report Key: 18173964
• Report Number: MW5148311
• Device Sequence Number: 7611195
• Product Code: FRN
• UDI-Device Identifier: 00856038001089
• UDI-Public: 00856038001089
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3860+
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEXMEDETOMIDINE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White