MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM MRI INFUSION PUMP

Model Number 3850

Device Problem Underdelivery (2343)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

A customer had contacted iradimed corporation for assistance in determining if the pump was involved with an event.Patient was receiving a heparin drip at 12 ml/hr.The mri scan ran for approximately 45 to 60 minutes.After return from the mri, the heparin bag was empty.The patient was monitored following the event, and untoward effects resulted from the event.No patient injury resulted from this event.The customer was questioning if any changes were made to the pump after it was programmed to run at 12 ml/hr.

Manufacturer Narrative

A hospital's biomedical engineer provided the suspect pump's history event log for review on march 25, 2015.This pump is at the customer's facility, and not has not been provided to iradimed corporation for examination.The log was reviewed and details provided to the customer on march 27.From this review, it appears this pump was not used on the day of the event, which the customer confirmed occurred on (b)(6).The hospital's biomedical engineer verified the time and date, and also confirmed the pump's time/date were correctly set on this pump.The customer has two other similar mridium 3850 pumps, and it was requested that the other pumps' logs should be examined to determine if one of these other pumps was the pump involved with the event.Customer has agreed to provided the requested information.Additional details and follow up information form the customer will be provided within 45 days of this report.

• Brand Name: MRIDIUM MRI INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): IRADIMED CORPORATION; winter spring FL
• Manufacturer Contact: francis casey ; 1025 willa springs drive; winter springs, FL 32708 ; 4076778022
• MDR Report Key: 4674127
• MDR Text Key: 20772306
• Report Number: 3005053560-2015-00004
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MRIDIUM 1056 INFUSION SET