FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PT CONNECT
MDR report key: 3050407
·
Received April 8, 2013
Report
- Report Number
- 8030665-2013-00192
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 12, 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 MFR FOR PHYSICAL EVAL AND THE COMPLAINT IS CONFIRMED. 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 TREATMENT WHEN THE LEAK OCCURRED. PT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144403 | LIBERTY CYCLER SET, DUAL PT CONNECT | LIBERTY DIALYSIS CYCLER TUBIN | FKX | REYNOSA MANUFACTURING | 12JR08092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |