FDA Adverse Event
Malfunction
Summary report: N
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
MDR report key: 3141007
·
Received June 3, 2013
Report
- Report Number
- 1416980-2013-13993
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Report Date
- April 5, 2013
- Manufacturer
- BAXTER HEALTHCARE - MOUNTAIN HOME
- Product Code
- FKX
- PMA / PMN Number
- K923065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A VISUAL INSPECTION AND LEAK TESTING NOTED CUTS IN THE PATIENT AND DRAIN LINES. CLEAR PASSAGE AND CLAMP FUNCTION TESTING WAS PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM. THE CAUSE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.
Description of Event or Problem · 1
A CASSETTE SAMPLE WAS RECEIVED FOR AN UNRELATED EVENT. WHEN THE SAMPLE WAS EVALUATED, IT WAS NOTED THAT THE PATIENT AND DRAIN LINES WERE CUT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244241 | HOMECHOICE AUTOMATED PD SET WITH CASSETTE | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | BAXTER HEALTHCARE - MOUNTAIN HOME |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HOMECHOICE |