FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 2243579
·
Received August 19, 2011
Report
- Report Number
- 8030665-2011-00087
- Event Type
- Malfunction
- Date Received
- August 19, 2011
- Date of Event
- May 9, 2011
- Report Date
- August 17, 2011
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE MANUFACTURING FACILITY RECEIVED COMPANION SAMPLES OF LOT# 11BR08010. SAMPLE ANALYSIS: A VISUAL ANALYSIS OF THE COMPANION SAMPLES WAS PERFORMED AND NO DEFECTS WERE FOUND. A FUNCTIONAL TEST WITH THE SAMPLES ON THE LIBERTY CYCLER WAS PERFORMED AND NO LEAKS OR ALARMS WERE FOUND DURING THE SIMULATED TREATMENT. CONCLUSION: THE COMPLAINT IS DEEMED AS UNCONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED. EVENT DATA WILL BE TRENDED PER QUALITY DATA ANALYSIS PROCEDURE.
Description of Event or Problem · 1
A PERITONEAL DIALYSIS PT REPORTED A LEAKING CASSETTE. REPORTEDLY, WHEN HE REMOVED THE CASSETTE FROM THE CYCLER HE NOTICED IT WAS LEAKING. THERE IS NO REPORT OF PT ILL EFFECT. HE DID NOT KEEP THIS CASSETTE.
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 | 11BR08010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | LIBERTY DIALYSIS MACHINE |