FDA Adverse Event
Malfunction
Summary report: N
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
MDR report key: 1230565
·
Received November 17, 2008
Report
- Report Number
- 6000001-2007-88601
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- May 29, 2007
- Report Date
- May 29, 2007
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FRN
- PMA / PMN Number
- K915523
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE PUMP WAS EVALUATED BY A BAXTER SERVICE TECHNICIAN. THE REPORTED CONDITION WAS CONFIRMED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE BY BAXTER, A BROKEN DOOR ON PUMP 1 WAS FOUND. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE | 80FRN | FRN | BAXTER HEALTHCARE | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |