FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3925058
·
Received February 5, 2014
Report
- Report Number
- 1314492-2014-06289
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- January 1, 2014
- Report Date
- January 9, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE EVALUATION COULD NOT REPRODUCE THE REPORTED SYSTEM ERROR 105. REVIEW OF THE HISTORY LOG CONFIRMED THE REPORTED SYSTEM ERROR 105. EVALUATION FOUND A SEIZING MOTOR. THE MOTOR ASSEMBLY WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP HAS A SYSTEM ERROR 105. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76070 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |