FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PT CONNECT
MDR report key: 3969898
·
Received April 25, 2014
Report
- Report Number
- 8030665-2014-00319
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- March 30, 2014
- Report Date
- March 31, 2014
- Manufacturer
- REYNOSA PLANT
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MDR 8060665-2014-00318.
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. PT HAD NO ILL EFFECTS AND COMPLETED TREATMENT MANUALLY. EFFLUENT REMAINED CLEAR. THE USED CASSETTE WAS RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250626 | LIBERTY CYCLER SET, DUAL PT CONNECT | FKX | REYNOSA PLANT | 13PR08056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |