MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM MRI INFUSION PUMP

Model Number 3860

Device Problems Inaccurate Flow Rate (1249); Underdelivery (2343)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2015

Event Type  malfunction  

Event Description

During an mri scan, a patient's infusion was started with propofol.A short time after the infusion was started, the nurse observed that she thought the infusion was delivering faster than programmed.This infusion was programmed for 15 ml/hr.The infusion was discontinued without harm to the patient, and it is believed the mr procedure continued without further incident.No patient injury resulted from this event.

Manufacturer Narrative

Investigation conclusions: the examination of the pump determined the 3860 pump was slightly outside the specified flow rate accuracy, but his issue did not contribute to the event.No specific problem was identified with the pump that could have caused this event.The infusion set used during the event was not examined by iradimed corporation.From the information available, no firm conclusions can be made as to what caused this event.From the examination of the pump used during the event, the history event log assessment, and information from the hospital staff using the pump, the probable cause of this report was the stretching of the infusion set in the pump by the user.The proper method of installation is described in the operator's manual.The instructions warn that stretching the tubing can result in free-flow conditions.In august 2012, iradimed corporation initiated correction no.3005053560-09/17/2012-002-c on 8/31/2012 to notify users of the possibility of this risk.These same instructions are provided in the operator's manual, but an additional instruction card was provided to users to emphasize these important instructions and precautions.The customer did have the instruction card available where this pump was being used.Copies of the correction and instruction card text are provided with this report in attachment 4.This is the second reported event from this same hospital within a 13 month period.In both instances, the infusion sets used both contained the older the blue sleeve protector that, when removed aggressively, can result in the tubing becoming stretched.These protectors were removed from the iradimed corporation infusion sets in (b)(6) 2012.The infusion set used during the event was manufactured prior to october 2012.The hospital believed all of the older infusion sets with the blue protectors had been removed from their user areas.They have re-examined their infusion set stock, and confirmed this has been completed on march 23, 2015.Follow-up in-service training is being recommended by iradimed corporation to the facility's staff.

• Brand Name: MRIDIUM MRI INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): IRADIMED CORPORATION; winter springs FL
• Manufacturer Contact: francis casey ; 1025 willa springs drive; winter springs, FL 32708 ; 4076778022
• MDR Report Key: 4641618
• MDR Text Key: 16458620
• Report Number: 3005053560-2015-00003
• 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: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3860
• Device Catalogue Number: 3860
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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 (LOT LBE006)
• Patient Outcome(s): Required Intervention