MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM MRI IV INFUSION SET

Model Number 1057

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Overdose (1988)

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

Hospital reporter provided infusion set used during the event.Examination of the infusion set indicated a stretched or longer than expected segment of tubing, which if used, could account for a free-flow condition.Product labeling describes proper installation and inspection of the infusion set prior to use to prevent a free-flow condition.Manufacturer is awaiting additional samples of 1057 infusion sets from the customer site for comparison with infusion set used during the event.A follow up report with added information will be provided within 45 days of this report.

Event Description

The nurse reported that during a patient infusion in the mri, the patient received an excess volume of 13.7 ml of propofol during the infusion.No injury was reported.

• Brand Name: MRIDIUM MRI IV INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): IRADIMED CORPORATION; winter springs FL
• Manufacturer Contact: francis casey ; 1025 willa springs drive; winter springs, FL 32708 ; 4076778022
• MDR Report Key: 4960953
• MDR Text Key: 23349318
• Report Number: 3005053560-2015-00009
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 1057
• Device Catalogue Number: 1057-50
• Device Lot Number: 15C31N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 14