FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 3123877
·
Received May 15, 2013
Report
- Report Number
- 8030665-2013-00283
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 17, 2013
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE COMPLAINT IS CONFIRMED DURING THE FUNCTIONAL TEST; THE CONNECTOR LEAKED DURING PRIMING STAGE. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING 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 PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING AND THE PATIENT CONNECTOR DURING TREATMENT. RN STATED THE PATIENT WAS ADMINISTERED PROPHYLACTIC ANTIBIOTICS AS A PRECAUTION. PATIENT IS DOING OKAY AND EXPERIENCED NO ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215022 | LIBERTY CYCLER SET, DUAL PATIENT CONNECT | FKX22 | FKX | REYNOSA MANUFACTURING | 12LR08084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY DIALYSIS CYCLER |