MAUDE Adverse Event Report: IRADIMED CORP. IRADIMED 1056 IV SET, STERILE DISP, W / DRIP CHAMBER; PUMP, INFUSION

Model Number	1056
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Diminished Pulse Pressure (2606)
Date of Event	03/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Mri ordered for evaluation of patient's neurological status concerning of anoxic brain injury in the setting of cardiac arrest.Mri standard tubing that was being used with norepinephrine developed a leak/hole/crack in the tubing between the pump and patient after getting into the mri room.Patient was very dependent on her medications keeping her blood pressure up.After lining up the table to the scanner, nurse noted small liquid drips starting to appear on the floor.After following/feeling tubing, determined the outside of the tubing was wet, but nurse could not locate the hole.Medication was immediately transferred to a different tubing.Tubing was later tested/flushed looking for a hole and one was found.No tubing leaks or blood pressure problems prior to entering mri room.Tubing was from groin on top of patient in full view on transfer into mri room and was never caught or pinched anyplace.Patient's blood pressure dropped due to tubing change, she was slow to recover.Showed no arrhythmia on monitor but lost her pulse.Code blue called, pulse recovered after 2 min of cpr, 1mg epinephrine, and blood pressure meds catching up.Mri was aborted.Bp somewhat labile in the process of transferring patient back to bed, and levophed increased to 30mcg/min to keep map >65.

• Brand Name: IRADIMED 1056 IV SET, STERILE DISP, W / DRIP CHAMBER
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): IRADIMED CORP.; 1025 willa springs drive; winter springs FL 32708
• MDR Report Key: 13964403
• Report Number: 13964403
• Device Sequence Number: 4176402
• Product Code: FRN
• UDI-Device Identifier: 00856038001027
• UDI-Public: 00856038001027
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2022
• Report Date (Section F): 03/29/2022

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
• Device Model Number: 1056
• Device Catalogue Number: IVP1056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/29/2022