FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3221958
·
Received July 5, 2013
Report
- Report Number
- 1314492-2013-01011
- Event Type
- Malfunction
- Date Received
- July 5, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 6, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION CONFIRMED THE DEVICE TO ALARM FOR AIR IN LINE. THIS WAS CAUSED BY THE UPSTREAM SENSOR VALUES BEING BELOW SPECIFICATION. THIS WAS DUE TO A FAILED UPSTREAM SENSOR. LOW ULTRASONIC READINGS WOULD CAUSE A PUMP TO BE MORE SENSITIVE TO AIR IN LINE AND UPSTREAM OCCLUSIONS. THE FAILED UPSTREAM SENSOR WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP CONSTANTLY ALARMED FOR AIR IN LINE WHEN NO AIR WAS PRESENT DURING A PREVENTIVE MAINTENANCE TEST. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307359 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |