FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 5090680
·
Received September 21, 2015
Report
- Report Number
- 1314492-2015-09388
- Event Type
- Malfunction
- Date Received
- September 21, 2015
- Date of Event
- August 27, 2015
- Report Date
- August 28, 2015
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE SYSTEM ERROR 105, WHICH WAS OBSERVED DURING POWER UP. SYSTEM ERROR 105 WAS CONFIRMED AND CAUSED BY A FAILED MOTOR FLEX. THE DEVICE WILL BE SCRAPPED DUE TO OTHER ISSUES UNRELATED TO THE REPORTED SYMPTOM.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 105 IN THE INTENSIVE CARE UNIT. IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622160 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |