FDA Adverse Event
Summary report: N
FMS 2000
MDR report key: 492346
·
Received October 10, 2003
Report
- Report Number
- MW1029888
- Date Received
- October 10, 2003
- Manufacturer
- BELMONT INSTRUMENT CORP.
- Product Code
- FRN
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
WAS TOLD THE FMS-2000 WAS HAVING PROBLEMS IN THE O.R. IN REGARDS TO THE FMS 2516 UNIVERSAL 3-SPIKE DISPOSABLE SET EXPLODING INSIDE THE UNIT WHILE BEING PRIMED AND ON ANOTHER OCCASION THE UNIT WAS BEING USED ON A PT IN THE O.R. WHEN IT EXPLODED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FMS 2000 | FLUID MANAGEMENT SYSTEM | FRN | BELMONT INSTRUMENT CORP. | FMS 2000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |