FDA Adverse Event
Injury
Summary report: N
MEDFUSION 3500 SYRINGE INFUSION PUMP
MDR report key: 1091843
·
Received July 31, 2008
Report
- Report Number
- 2183502-2008-00208
- Event Type
- Injury
- Date Received
- July 31, 2008
- Date of Event
- July 6, 2008
- Report Date
- July 31, 2008
- Manufacturer
- SMITHS MEDICAL MD
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE SUSPECT DEVICE HAS BEEN RETURNED AND IS CURRENTLY BEING EVALUATED. A FOLLOW UP REPORT WILL BE SENT ONCE THE EVALUATION IS COMPLETED.
Description of Event or Problem · 1
AN IV DRIP BAG WAS BEING CHANGED DIRECTLY ABOVE THE DEVICE. SOME OF THE IV FLUID DRIPPED DIRECTLY ON THE DEVICE AND POWER CORD USING A SHORT. THE DEVICE BEGAN "SHOOTING SPARKS" AND FILLED THE NICU WITH SMOKE. THERE WAS NO PT INJURY BUT DID REQUIRE AN EVACUATION OF THE NICU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDFUSION 3500 SYRINGE INFUSION PUMP | SYRINGE INFUSION PUMP | FRN | SMITHS MEDICAL MD | 3500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE | Required Intervention |