FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
MDR report key: 3063697
·
Received April 12, 2013
Report
- Report Number
- 8030665-2013-00204
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 15, 2013
- Manufacturer
- REYNOSA MFG
- Product Code
- FKX
- PMA / PMN Number
- K043363
- 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 MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG 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. UPON REMOVING THE TUBING SET FROM THE CYCLER, FLUID WAS NOTICED IN THE CASSETTE COMPARTMENT. PT HAD NO ADVERSE EFFECTS FROM THE CASSETTE LEAK. SAMPLE WAS DISCARDED BY THE PT; SAMPLE IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 158130 | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL | LIBERTY DIALYSIS CYCLER TUBING | FKX | REYNOSA MFG | 13AR08886 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |