FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 5113219
·
Received September 30, 2015
Report
- Report Number
- 1314492-2015-09614
- Event Type
- Malfunction
- Date Received
- September 30, 2015
- Date of Event
- August 31, 2015
- Report Date
- September 8, 2015
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REF. NO.: (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 FAILED MOTOR ASSEMBLY, BEARINGS AND GEARS WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 105 IN THE NEUROLOGY UNIT. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 644233 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |