MAUDE Adverse Event Report: IRADIMED CORPORATION IRADIMED 1056 INFUSION SET

Model Number	1056
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Examination of the actual device involved in the patient event showed evidence of the infusion set tubing having been pinched and then either torn or cut.This is not consistent with a manufacturing defect.
Event or Problem Description
It was reported that after the patient was moved into the mr scanner, the tubing connected to the infusion pump was leaking.The patient was being infused with norepinephrine and the leak resulted in a replacement infusion set needing to be installed.Following the replacement of the infusion set, the patient's blood pressure dropped and a code blue was called.Patient's pulse recovered, but the mri was aborted.

• Brand Name: IRADIMED 1056 INFUSION SET
• Common Device Name: INFUSION SET
• 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: 14253577
• Report Number: 3005053560-2022-00002
• Device Sequence Number: 4773790
• Product Code: FRN
• UDI-Device Identifier: 00856038001027
• UDI-Public: 00856038001027
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1056
• Device Catalogue Number: IVP1056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Unknown