FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3221539
·
Received July 3, 2013
Report
- Report Number
- 1314492-2013-00983
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 4, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP.
- 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). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVAL FOUND THE LOW READINGS ON THE ULTRASONIC SENSOR CAUSED BY A FAILED UPSTREAM SENSOR. WITH LOW ULTRASONIC READINGS IT WOULD MAKE THE PUMP MORE SENSITIVE TO UPSTREAM OCCLUSION ALARMS. THE UPSTREAM SENSOR WILL BE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP ALARMS FOR UPSTREAM OCCLUSION WHEN NO OCCLUSION IS PRESENT. THE CUSTOMER ALSO STATED THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304658 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP. | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |