FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./EXT.DL
MDR report key: 2894658
·
Received December 27, 2012
Report
- Report Number
- 8030665-2012-00413
- Event Type
- Malfunction
- Date Received
- December 27, 2012
- Date of Event
- December 5, 2012
- Report Date
- December 5, 2012
- Manufacturer
- REYNOSA MFG
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CAN NOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG 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. FLUID WAS NOTICED INSIDE THE CYCLER DOOR AFTER REMOVING THE CASSETTE FOLLOWING TREATMENT. PT WAS NOT ABLE TO IDENTIFY THE ORIGIN OF THE LEAK. PT HAD NO ILL EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTY CYCLER SET, SINGLE CONN./EXT.DL | LIBERTY DIALYSIS CYCLER TUBING | FKX | REYNOSA MFG | 12KR08053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |