FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG
MDR report key: 1230789
·
Received November 17, 2008
Report
- Report Number
- 1423500-2007-00085
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- January 15, 2007
- Report Date
- January 15, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
BAXTER REPORTED A HOMECHOICE CASSETTE LEAK. THE LEAK OCCURRED BEFORE USE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN THE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG | HOMECHOICE CASSETTE | FKX | BAXTER HEALTHCARE CORPORATION | NA | H06106044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |