FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./EXT.DL
MDR report key: 2243497
·
Received August 19, 2011
Report
- Report Number
- 8030665-2011-00074
- Event Type
- Malfunction
- Date Received
- August 19, 2011
- Date of Event
- April 5, 2011
- Report Date
- August 15, 2011
- Manufacturer
- REYNOSA MFG.
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE MFG FACILITY RECEIVED SIX SAMPLES FROM (B)(4), LOT #10SR08007. THIS LOT NUMBER IS DIFFERENT THAN THE LOT NUMBER REPORTED BY THE PT. SAMPLE ANALYSIS: A FUNCTIONAL TEST WAS PERFORMED ON ALL THE COMPANION SAMPLES WITH THE LIBERTY CYCLER MACHINE IN ORDER TO FINS ANY PROBLEM OR ALARM RELATED TO THE FAILURE MODE. CONCLUSION: THE RESULT OF THE TEST SHOWS THE MACHINE PERFORMED THE SET UP AND THE REST OF THE TREATMENT WITHOUT ANY ISSUES OR ALARMS. THEREFORE, 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 CASSETTE WAS FULL OF FLUID. THERE IS NO REPORT OF PT ILL EFFECT. THE SAMPLE IS AVAILABLE FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTY CYCLER SET, SINGLE CONN./EXT.DL | PERITONEAL DIALYSIS TUBING SET | FKX | REYNOSA MFG. | NA | 11AR08020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | LIBERTY DIALYSIS MACHINE |