FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3182492
·
Received June 11, 2013
Report
- Report Number
- 1314492-2013-00745
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 13, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE EVALUATION COULD NOT CONFIRM THE REPORTED SYMPTOM OF "UPSTREAM OCCLUSION TEST IS FAILING, DOES NOT ALARM." UPSTREAM OCCLUSION TEST WAS PERFORMED PER SPECTRUM SERVICE MANUAL (PM INSPECTION) WITH UNIT PASSING. THE UNIT ALSO PASSED ADDITIONAL UPSTREAM OCCLUSION TESTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DEVICE WAS UNABLE TO DETECT AN UPSTREAM OCCLUSION DURING TESTING. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264744 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |