FDA Adverse Event
Malfunction
Summary report: N
MEDRAD INFUSION PUMP
MDR report key: 2010856
·
Received February 15, 2011
Report
- Report Number
- 2010856
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Report Date
- July 2, 2010
- Manufacturer
- MEDRAD
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
AFTER COMPLETION OF SEDATED MRI PROCEDURE, MRI INFUSION PUMP DID NOT SHUT OFF AFTER INFUSION WAS COMPLETED. TWO FEET OF AIR FOUND IN LINE AND VIDEO OBTAINED TO SHOE VENDOR, PATIENT DISCHARGE HOME IN STABLE CONDITION. RADIOLOGY STAFF CONTACTED MANUFACTURER AND SENT PROBLEM INFUSION PUMP BACK UNDER THE SERVICE EXCHANGE PROGRAM. THE MANUFACTURER SENT NEW PUMP BACK TO HOSPITAL. THE NEW PUMP WAS PUT INTO SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDRAD INFUSION PUMP | INFUSION PUMP | FRN | MEDRAD | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR |