FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3934122
·
Received February 1, 2014
Report
- Report Number
- 1314492-2014-07305
- Event Type
- Malfunction
- Date Received
- February 1, 2014
- Date of Event
- January 14, 2014
- Report Date
- January 14, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND EVALUATED. THE EVALUATION EXPERIENCED FALSE UPSTREAM OCCLUSION ALARMS CAUSED BY CRACKS IN THE UPSTREAM SENSOR TAIL PINS. THE FAILED UPSTREAM SENSOR WAS REPLACED.
Description of Event or Problem · 1
IT WAS FOUND DURING A BAXTER EVALUATION THAT A PUMP HAS FALSE UPSTREAM OCCLUSION ALARMS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69373 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |