FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG
MDR report key: 1230865
·
Received November 17, 2008
Report
- Report Number
- 1423500-2007-00121
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- February 1, 2007
- Report Date
- February 12, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
BAXTER REPORTED LEAKAGE OF SOLUTION FROM THE CONNECTION BETWEEN THE HOMECHOICE CASSETTE AND THE MACHINE. THE HOMECHOICE MACHINE ALARMED AND MADE THE PATIENT AWARE OF THE LEAK. HE TRIED WITH THREE DIFFERENT UNITS (THE SAME BATCH) AND HE FOUND THE SAME ISSUE. 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 | S06109055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |