FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 5212155
·
Received November 9, 2015
Report
- Report Number
- 1314492-2015-10709
- Event Type
- Malfunction
- Date Received
- November 9, 2015
- Date of Event
- October 1, 2015
- Report Date
- October 16, 2015
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 REPORTED SYSTEM ERROR 105, WHICH WAS REPRODUCED AT POWER UP. SYSTEM ERROR 105 WAS ALSO CONFIRMED THROUGH A REVIEW OF THE EVENT HISTORY LOG AND CAUSED BY A SEIZED MOTOR. THE MOTOR, BEARINGS AND GEARS WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 105. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 741501 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |