FDA Adverse Event
Malfunction
Summary report: N
AS50 INFUSION PUMP
MDR report key: 1220771
·
Received October 31, 2008
Report
- Report Number
- 6000001-2008-00689
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- October 13, 2008
- Report Date
- October 14, 2008
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- FPA
- PMA / PMN Number
- K961225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED IN BAXTER, BUT HAS NOT YET BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN AN EVALUATION IS COMPLETED.
Description of Event or Problem · 1
THE FACILITY REP REPORTED A PUMP WITH AN OVERINFUSION DURING PT USE. CONTACT WITH THE FACILITY HAS NOT PRODUCED ANY ADD'L INFO. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AS50 INFUSION PUMP | 80FPA | FPA | BAXTER HEALTHCARE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |