FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE CYCLER-REFURBISHED
MDR report key: 1040691
·
Received May 8, 2008
Report
- Report Number
- 1423500-2008-00325
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- April 16, 2008
- Report Date
- April 16, 2008
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FKX
- PMA / PMN Number
- K012988
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING FEELING UNCOMFORTABLY FULL DURING DWELL 3/6. THE PATIENT FELT DISTENDED. THE ULTRAFILTRATION WAS -345ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) STARTED A MANUAL DRAIN AND DRAINED 2660ML. THE LAST VOLUME INFUSED WAS 2000ML. THE HOME PATIENT STATED SHE IS A SLOW DRAINER. SHE WILL BE CALLING THE NURSE TO CHANGE THE MINIMUM DRAIN PERCENTAGE. HOME PATIENT DID NOT WANT TO END THERAPY AT THAT TIME. TSR STAYED ON THE PHONE WITH THE HOME PT WHILE SHE CONTINUED THERAPY. NO FURTHER INFO REGARDING THIS EVENT COULD BE OBTAINED DESPITE MULTIPLE ATTEMPTS BY BAXTER. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
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 |