FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3061379
·
Received March 26, 2013
Report
- Report Number
- 1314492-2013-00290
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 26, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION CONFIRMED THE ULTRASONIC SENSOR READING TO BE BELOW SPECIFICATION CAUSED BY A FAILED UPSTREAM SENSOR. A LOW ULTRASONIC SENSOR READING WILL CAUSE THE PUMP TO BECOME MORE SENSITIVE TO AIR IN THE IV SET. THE ULTRASONIC SENSOR WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP ALARMS CONSTANTLY FOR AIR-IN-LINE. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123057 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |