FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 4810569
·
Received May 29, 2015
Report
- Report Number
- 1314492-2015-06408
- Event Type
- Malfunction
- Date Received
- May 29, 2015
- Date of Event
- May 1, 2015
- Report Date
- May 6, 2015
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPEC IN RELATION TO THE SYSTEM ERROR WHICH WAS REPRODUCED AT POWER UP. SYSTEM ERROR 105 WAS CONFIRMED AND CAUSED BY SEVERED MOTOR MOUNT SCREWS. THE FAILED MOTOR ASSEMBLY AND SCREWS 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 PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349661 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |