FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3- PRONG
MDR report key: 1201905
·
Received October 21, 2008
Report
- Report Number
- 1423500-2007-00074
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- January 19, 2007
- Report Date
- January 19, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON FEB 16 2007.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CENTER REGARDING A LEAKING CASSETTE DURING DRAIN 2 OF 4 OF THERAPY ON THE HOMECHOICE SYSTEM. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HOME PATIENT TO END THE THERAPY. THERAPY WAS RESTARTED WITH NEW SUPPLIES AND THERE WERE NO FURTHER PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT, PER THE HOME PATIENT'S WIFE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3- PRONG | HOMECHOICE CASSETTE | FKX | BAXTER HEALTHCARE CORPORATION | NA | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CAPD TRANSFER SET| MINICAP DISCONNECT CAP| DIANEAL PD 2 SOLUTION (STRENGTH UNKNOWN)| HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT |