FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
MDR report key: 3063276
·
Received March 1, 2013
Report
- Report Number
- 8030665-2013-00121
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 4, 2013
- Report Date
- February 5, 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 ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE COMPLAINT IS CONFIRMED WITH 6 PINHOLES ON THE CASSETTE FILM. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. 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. THE PATIENT'S NURSE REMOVED THE CASSETTE AND NOTICED FLUID INSIDE THE CYCLER DOOR. PATIENT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89888 | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL | LIBERTY DIALYSIS CYCLER TUBING | FKX | REYNOSA MANUFACTURING | 12LR08035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |