FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 2071245
·
Received April 27, 2011
Report
- Report Number
- 1423500-2011-05100
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- November 8, 2010
- Report Date
- November 9, 2010
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BAXTER TO REPORT A SOLUTION LEAK WITH A CASSETTE. THE CUSTOMER STATED THE LEAK OCCURRED DURING PRIMING. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. ON (B)(6) 2010, FURTHER INFORMATION OBTAINED FROM THE CUSTOMER INDICATED THAT THE LEAK WAS COMING FROM THE TOP OF THE CASSETTE NEAR THE PATIENT LINE. THIS IS REPORT 1 OF 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME | H10G22114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |