FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3880131
·
Received January 30, 2014
Report
- Report Number
- 1314492-2014-05100
- Event Type
- Malfunction
- Date Received
- January 30, 2014
- Date of Event
- January 3, 2014
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
MFR REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF COMPLAINT (B)(4). THE UNDETECTED UPSTREAM OCCLUSION EXPERIENCED DURING TESTING WAS NOT ABLE TO BE REPRODUCED, AND THE DEVICE WAS DETERMINED TO BE WITHIN SPECIFICATION.
Description of Event or Problem · 1
DURING BAXTER'S DEVICE EVALUATION, THE DEVICE FAILED TO DETECT AN UPSTREAM OCCLUSION. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65052 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |