MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM INFUSION SET

Model Number 1056

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Iradimed has received the product for evaluation, and the investigation is in process. A follow up report will be provided after the product investigation has been completed by iradimed corporation. (b)(4).

Event Description

During an mri infusion of levophed, the nurse reported patient called her into the mr scanner room to inform her the iv set being used was leaking. The nurse described that the infusion set had a 5 cm tear in the silicone pump chamber tubing. No information was provided as to the source of the tear in the tubing. The infusion set was quickly replaced to continue the infusion. The patient's blood pressure initially dropped, but recovered when the infusion set was replaced. No patient injury was reported.

• Brand Name: MRIDIUM INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): IRADIMED CORPORATION; 1025 willa springs drive; winter springs FL 32708 5235
• Manufacturer (Section G): IRADIMED CORPORATION; 1025 willa springs drive; winter springs FL 32708 5235
• Manufacturer Contact: francis casey ; 1025 willa springs drive; winter springs, FL 32708-5235 ; 4076778022
• MDR Report Key: 8810096
• MDR Text Key: 151735742
• Report Number: 3005053560-2019-00003
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/21/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2021
• Device Model Number: 1056
• Device Catalogue Number: 1056
• Device Lot Number: 19A16N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial