FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3934126
·
Received February 1, 2014
Report
- Report Number
- 1314492-2014-07309
- Event Type
- Malfunction
- Date Received
- February 1, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS REC'D AND EVALUATED BY BAXTER. THE REPORTED SYMPTOM WAS CONFIRMED AND REPRODUCED. TESTING EXPERIENCED A FALSE UPSTREAM OCCLUSION ALARM DURING WARM UP. THIS WAS CAUSED BY A FAILED UPSTREAM SENSOR. THE FAILED UPSTREAM SENSOR WAS REPLACED.
Description of Event or Problem · 1
IT WAS DISCOVERED IN TESTING THAT A PUMP DISPLAYED A FALSE UPSTREAM OCCLUSION ALARM. THERE WAS NO PATIENT INVOLVEMENT, AS THE MALFUNCTION WAS DISCOVERED IN TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69280 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |