FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG
MDR report key: 1230894
·
Received November 17, 2008
Report
- Report Number
- 1423500-2007-00139
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- February 24, 2007
- Report Date
- February 26, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BAXTER'S PRODUCT SURVEILLANCE DEPARTMENT IS PURSUING ADDITIONAL INFORMATION REGARDING THIS INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
A CUSTOMER REPORTED A HOMECHOICE AUTOMATED PERITONEAL DIALYSIS (APD) CASSETTE WITH A LEAKING DRAIN LINE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG | HOMECOICE CASSETTE | FKX | BAXTER HEALTHCARE CORPORATION | NA | H06I26018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DIANEAL 4.25% DEXTROSE LOW-CALCIUM SOLUTION| 15 LITER DRAINAGE BAG| DIANEAL 2.5% DEXTROSE LOW-CALCIUM SOLUTION| HOMECHOICE AUTOMATED PD SYSTEM 110 VOLT| MINICAP DISCONNECT CAP| DIANEAL 1.5% DEXTROSE LOW-CALCIUM SOLUTION |