FDA Adverse Event
Malfunction
Summary report: N
INFUSO.R.
MDR report key: 2120916
·
Received June 12, 2011
Report
- Report Number
- 6000001-2011-07549
- Event Type
- Malfunction
- Date Received
- June 12, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 18, 2011
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K883577
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED CONDITION OF FALSE OCCLUSION ALARM DURING INITIAL RUN WAS CONFIRMED THROUGH EVALUATION AND WAS FOUND TO BE DUE TO THE WIRE BEING ROUTED INCORRECTLY AROUND THE OCCLUSION SWITCH LEVER. THE BATTERY WIRE WAS RE-ROUTED TO CORRECT THE CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
A BAXTER SERVICE TECHNICIAN REPORTED FINDING AN INFUSOR PUMP WITH "FALSE OCCLUSION ALARM DURING INITIAL RUN." THIS EVENT OCCURRED DURING PRODUCT EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSO.R. | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |