FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 3904921
·
Received May 28, 2014
Report
- Report Number
- 8030665-2014-00448
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 1, 2014
- 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 DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.
Description of Event or Problem · 1
A PERITONEAL DIALYSIS (PD) PATIENT REPORTED FINDING A FLUID LEAK FOLLOWING HER TREATMENT. WHEN SHE OPENED THE CASSETTE DOOR FLUID BEGAN TO LEAK OUT. THE SET WAS RETAINED AND WILL BE MADE AVAILABLE FOR EVALUATION. DURING FOLLOW UP, THE PATIENT REPORTED THAT HER EFFLUENT HAS REMAINED CLEAR. THE PATIENT NOTIFIED HER PD NURSE AND NO ANTIBIOTICS WERE PRESCRIBED. NO ADVERSE EVENT REPORTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315092 | LIBERTY CYCLER SET, DUAL PATIENT CONNECT | FKX | REYNOSA MANUFACTURING | 13PR08058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LIBERTY CYCLER |