FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 2932426
·
Received January 24, 2013
Report
- Report Number
- 8030665-2013-00054
- Event Type
- Malfunction
- Date Received
- January 24, 2013
- Date of Event
- December 26, 2012
- Report Date
- December 28, 2012
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
A PERITONEAL DIALYSIS PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER DURING TREATMENT. UPON REMOVING THE TUBING SET, FLUID WAS FOUND LEAKING INTO THE CYCLER. PT HAD NO ILL EFFECTS. AS OF THIS WRITING, SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34671 | LIBERTY CYCLER SET, DUAL PATIENT CONNECT | LIBERTY DIALYSIS CYCLER TUBING | FKX | REYNOSA MANUFACTURING | 12JR08096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |