FDA Adverse Event
Malfunction
Summary report: N
BELMONT
MDR report key: 2999911
·
Received February 4, 2013
Report
- Report Number
- 2999911
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 17, 2013
- Report Date
- February 4, 2013
- Manufacturer
- BELMONT INSTRUMENT CORPORATION
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
AFTER PRIMING, THE BELMONT TUBING WAS CONNECTED TO THE PATIENT'S TRIPLE LUMEN CENTRAL LINE FOR INFUSION. WHEN TRYING TO INCREASE RATE FROM 50ML/MIN THE SCREEN READ "BATTERY" AND WOULD NOT INCREASE INFUSION RATE EVEN AFTER CORDS AND PLUGS WERE CHECKED. EQUIPMENT PLUGGED INTO ANOTHER OUTLET AND WAS ABLE TO INFUSE AT 450ML/MIN AND ANOTHER MESSAGE "VALVE ERROR". TUBING WAS REMOVED, EQUIPMENT TURNED OFF AND TUBING REPLACED AND THE MESSAGE STILL APPEARED. NO CLAMPS OR KINKS IN ANY OF THE TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46585 | BELMONT | PUMP, INFUSION | FRN | BELMONT INSTRUMENT CORPORATION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |