FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL
MDR report key: 3042837
·
Received April 4, 2013
Report
- Report Number
- 8030665-2013-00180
- Event Type
- Malfunction
- Date Received
- April 4, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 6, 2013
- Manufacturer
- REYNOSA MANUFACTURING
- 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 EVALUATION 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 PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER DURING TREATMENT. PATIENT HAD NO ILL EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138393 | LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL | LIBERTY DIALYSIS CYCLER TUBING | FKX | REYNOSA MANUFACTURING | 12SR08013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |