FDA Adverse Event
Other
Summary report: N
SIGMA 8000
MDR report key: 641331
·
Received September 12, 2005
Report
- Report Number
- 641331
- Event Type
- Other
- Date Received
- September 12, 2005
- Report Date
- September 12, 2005
- Manufacturer
- SIGMA INTERNATIONAL
- Product Code
- FRN
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
SIGMA 8000 I.V. PUMP IS UNABLE TO DETECT A SMALL PIECE OF I.V. TUBING, ABOUT 2-3CM, LEFT IN THE IV SET CHANNEL OF THE PUMP. THE BIOMEDICAL DEPARTMENT HAS DEMONSTRATED THAT IF THIS SMALL PIECE OF TUBING REMAINS IN THE SET CHANNEL AND NEW PATIENT IV SET IS PLACED IN THE CHANNEL, THE PUMP HAS THE POTIENTIAL OF DELIVERING ABOUT DOUBLE THE SET AMOUNT. THE MANUFACTURER HAS BEEN NOTIFIED OF THIS PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGMA 8000 | I.V. PUMP | FRN | SIGMA INTERNATIONAL | 8000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |