FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE PT CONN
MDR report key: 2904693
·
Received January 4, 2013
Report
- Report Number
- 8030665-2013-00008
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 9, 2012
- Report Date
- December 9, 2012
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.
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 WAS IN FILL ONE AND NOTICED FLUID LEAKING OUT OF THE CYCLER. RN STATES THAT THE PT HAD NO ILL EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5340 | LIBERTY CYCLER SET, SINGLE PT CONN | LIBERTY DIALYSIS CYCLER TUBING | FKX | REYNOSA MANUFACTURING | 12KR08818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |