FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 4810554
·
Received May 29, 2015
Report
- Report Number
- 1314492-2015-06410
- 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
MFR REF NO: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPEC IN RELATION TO THE SYSTEM ERROR WHICH WAS REPRODUCED. SYSTEM ERROR 105 WAS CONFIRMED AND CAUSED BY A FAILED MOTOR WITH 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 |
|---|---|---|---|---|---|---|---|
| 349658 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |