FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 4447895
·
Received June 16, 2014
Report
- Report Number
- 1314492-2014-37441
- Event Type
- Malfunction
- Date Received
- June 16, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 22, 2014
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. THE EVAL CONFIRMED AND REPRODUCED THE REPORTED DOWNSTREAM OCCLUSION ALARMS. THE DOWNSTREAM PRESSURE PLATE HAP WAS OUT OF SPEC, RESULTING IN HIGH DOWNSTREAM SENSOR READINGS. THE DOWNSTREAM TUBING GUIDE WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP HAD A DOWNSTREAM OCCLUSION ALARM. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353725 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |