FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 3861059
·
Received April 14, 2014
Report
- Report Number
- 8030665-2014-00292
- Event Type
- Malfunction
- Date Received
- April 14, 2014
- Date of Event
- March 17, 2014
- Report Date
- March 17, 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 FOLLOWING TREATMENT, HE DISCOVERED A FLUID LEAK WHILE TAKING OUT THE CASSETTE. THE FLUID WAS ON THE PUMP MODULE. HE REPORTED THAT THERE WERE NO ALARMS DURING SETUP OR TREATMENT. A SAMPLE WAS RETAINED AND WILL BE MADE AVAILABLE FOR INVESTIGATION. DURING FOLLOW UP, THE PT'S NURSE REPORTED HIS EFFLUENT HAS REMAINED CLEAR. THERE WERE NO SIGNS OF INFECTION AND NO PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. NO ADVERSE EVENT REPORTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228184 | LIBERTY CYCLER SET, DUAL PATIENT CONNECT | FKX | REYNOSA MANUFACTURING | 13PR08056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | LIBERTY CYCLER |