FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 2241660
·
Received August 19, 2011
Report
- Report Number
- 8030665-2011-00051
- Event Type
- Malfunction
- Date Received
- August 19, 2011
- Date of Event
- November 9, 2010
- Report Date
- August 19, 2011
- Manufacturer
- REYNOSA MFG.
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY RECORD REVIEW: THE DHR CANNOT BE INVESTIGATED BECAUSE THE LOT NUMBER IS UNK. CONFIRMATION OF THE COMPLAINT: THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR THE EVAL. THE COMPLAINT IS NOT CONFIRMED. CORRECTIVE ACTION: THE SAMPLE WAS NOT AVAILABLE, THEREFORE, NO CORRECTIVE ACTION CAN BE PURSUED FOR THIS INCIDENT. FMC NA WILL CONTINUE TO MONITOR PER PROCEDURE.
Description of Event or Problem · 1
A REPORT HAS BEEN RECEIVED FROM A PERITONEAL DIALYSIS PT. THE PT REPORTED A CASSETTE LEAK. THE NURSE WAS CONTACTED AND THERE IS NO REPORT OF INJURY OR ILL EFFECT. THERE IS NO SAMPLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTY CYCLER SET, DUAL PATIENT CONNECT | PERITONEAL DIALYSIS TUBING SET | FKX | REYNOSA MFG. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | LIBERTY DIALYSIS MACHINE |