FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
MDR report key: 3060783
·
Received April 5, 2013
Report
- Report Number
- 8030665-2013-00189
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 8, 2013
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
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. UPON REMOVING THE TUBING SET FOLLOWING TREATMENT, FLUID WAS NOTICED ON THE BACK SIDE OF THE CASSETTE AND INSIDE THE CYCLER CASSETTE COMPARTMENT. PT HAD NO ILL EFFECTS. SAMPLE WAS DISCARDED BY THE USER FACILITY; SAMPLE IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139905 | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL | LIBERTY DIALYSIS CYCLER TUBING | FKX | REYNOSA MANUFACTURING | 12PR08810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |