FDA Adverse Event
Malfunction
Summary report: N
MRIDIUM MRI INFUSION PUMP
MDR report key: 2704165
·
Received August 13, 2012
Report
- Report Number
- 3005053560-2012-00004
- Event Type
- Malfunction
- Date Received
- August 13, 2012
- Date of Event
- July 10, 2012
- Report Date
- August 10, 2012
- Manufacturer
- IRADIMED CORPORATION
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN EXAMINED BY IRADIMED CORPORATION AND FOUND TO OPERATE WITHIN SPECIFICATION. THE INFUSION SET USED DURING THIS EVENT WAS DISCARDED BY THE HOSPITAL AND IS NOT AVAILABLE FOR INSPECTION. INVESTIGATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE FILED WITHIN 30 DAYS OF THIS REPORT.
Description of Event or Problem · 1
DURING AN MRI INFUSION, A PT RECEIVED AN OVER-INFUSION OF PROPOFOL. THE HOSPITAL REPORTED THE PT RECEIVED APPROXIMATELY 40 ML IN A SHORT PERIOD OF TIME. NO PT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRIDIUM MRI INFUSION PUMP | INFUSION PUMP | FRN | IRADIMED CORPORATION | 3860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |