FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 2243606
·
Received August 19, 2011
Report
- Report Number
- 8030665-2011-00076
- Event Type
- Malfunction
- Date Received
- August 19, 2011
- Date of Event
- April 7, 2011
- Report Date
- August 15, 2011
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO SAMPLE RETURNED FOR EVALUATION. THEREFORE, THE COMPLAINT IS DEEMED AS UNCONFIRMED. NO FURTHER INVESTIGATION REQUIRED. EVENT DATA WILL BE TRENDED PER QUALITY DATA ANALYSIS PROCEDURE.
Description of Event or Problem · 1
A PERITONEAL DIALYSIS PATIENT INDICATED THAT SHE WAS HAVING PROBLEMS WITH THE CYCLER AND FLUID LEAKING. THERE IS NO REPORT OF PATIENT ILL EFFECT. THERE IS NO SAMPLE AVAILABLE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTY CYCLER SET, DUAL PATIENT CONNECT | PERITONEAL DIALYSIS TUBING SET | FKX | REYNOSA MANUFACTURING | NA | 11AR08139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | LIBERTY DIALYSIS MACHINE |