FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM
MDR report key: 2444636
·
Received January 23, 2012
Report
- Report Number
- 2444636
- Event Type
- Malfunction
- Date Received
- January 23, 2012
- Date of Event
- January 17, 2012
- Report Date
- January 23, 2012
- Manufacturer
- SIGMA
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
Narratives
Description of Event or Problem · 1
PUMP FAILED TO INFUSE SODIUM PHOSHATE AT CORRECT RATE OVER 5 HOURS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRUM | INFUSION PUMP | FRN | SIGMA | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |