FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE CYCLER-REFURBISHED
MDR report key: 976119
·
Received December 4, 2007
Report
- Report Number
- 1423500-2007-01248
- Event Type
- Malfunction
- Date Received
- December 4, 2007
- Date of Event
- November 2, 2007
- Report Date
- November 6, 2007
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- PMA / PMN Number
- K012988
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL 510(K) NUMBER: K923065.
Description of Event or Problem · 1
A HOME PATIENT'S WIFE CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING AN OVERFILL ON A HOMECHOICE DEVICE. THE INCIDENT OCCURRED IN 2007. THE HOME PATIENT HAD FELT FULL AT THE END OF THERAPY. THE HOME PATIENT'S WIFE DRAINED 3800ML FROM THE PATIENT USING MANUAL BAGS. THE PATIENT'S LAST FILL VOLUME WAS 2498ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE HOMECHOICE THERAPY LOG AND FOUND THAT THE HOME PATIENT'S ULTRAFILTRATION (UF) WAS -408ML. THE TSR CALLED THE PATIENT'S NURSE AND DISCUSSED ADDING A LAST MANUAL DRAIN TO THE THERAPY TO PREVENT THIS IN THE FUTURE. THE HOME PATIENT'S UF RANGE WAS BETWEEN 125ML AND 2811ML OVER THE LAST 6 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE CYCLER-REFURBISHED | 78FKX | FKX | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |