FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN EXT DL
MDR report key: 4230802
·
Received October 27, 2014
Report
- Report Number
- 8030665-2014-00834
- Event Type
- Malfunction
- Date Received
- October 27, 2014
- Date of Event
- September 29, 2014
- Report Date
- September 30, 2014
- Manufacturer
- FRESENIUS MED CARE NORTH AMERICA REYNOSA MFG
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE COMPLAINT IS NOT CONFIRMED. AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMITIES 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 REPORTED THAT DIALYSIS SOLUTION LEAKED OUT OF THE CASSETTE AND INTO THE CYCLER. PT WAS ABLE TO COMPLETE TREATMENT. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED AND THERE IS NO OTHER KNOWN PT ILL EFFECTS. PT WAS FINE. SAMPLE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 681225 | LIBERTY CYCLER SET, SINGLE CONN EXT DL | FKX | FRESENIUS MED CARE NORTH AMERICA REYNOSA MFG | 14HR08092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PD SOLUTIONS| LIBERTY DIALYSIS CYCLER |