FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 4922095
·
Received July 17, 2015
Report
- Report Number
- 1314492-2015-07719
- Event Type
- Malfunction
- Date Received
- July 17, 2015
- Date of Event
- June 1, 2015
- Report Date
- June 25, 2015
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION WITH RESPECT TO THE REPORTED SYMPTOM "BLOCKED LINE". EVALUATION CONFIRMED THE REPORTED SYMPTOM "BLOCKED LINE" THROUGH REVIEW OF THE EVENT HISTORY LOG AS AN "UPSTREAM OCCLUSION ALARM". EVALUATION FOUND THE COMPONENT CAUSALITY TO BE A FAILED UPSTREAM SENSOR. THE UPSTREAM SENSOR WILL BE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP EXPERIENCED A BLOCKED LINE. IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466369 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |