FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
MDR report key: 3851741
·
Received April 22, 2014
Report
- Report Number
- 8030665-2014-00312
- Event Type
- Malfunction
- Date Received
- April 22, 2014
- Date of Event
- March 30, 2014
- Report Date
- March 30, 2014
- Manufacturer
- REYNOSA PLANT
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
A PERITONEAL DIALYSIS PT NOTED A FLUID LEAK AFTER COMPLETING TREATMENT. THE LEAK CAME THROUGH THE BAG CONNECTIONS BEFORE OPENING CASSETTE DOOR. TH FLUID LEAKED ONTO THE FLOOR NOT THE CYCLER. THERE WAS NO KNOWN PT ILL EFFECTS. PT HAS HAD NO INDICATION OF INFECTION, EFFLUENT REMAINED CLEAR. THE CYCLER WAS REPLACED AND NO FURTHER ISSUES SINCE. CASSETTE WAS BEEN DISCARDED THEREFORE THERE WAS NO SAMPLE WAS AVAILABLE FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243731 | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL | FKX | REYNOSA PLANT | 13PR08177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |