FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 4022981
·
Received July 11, 2014
Report
- Report Number
- 8030665-2014-00544
- Event Type
- Malfunction
- Date Received
- July 11, 2014
- Date of Event
- June 12, 2014
- Report Date
- June 13, 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
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 THERE WAS FLUID LEAKING FROM THE CASSETTE. SHE WAS ADVISED TO DISCONTINUE USING THE CYCLER AND TO CONTACT HER PD NURSE. THE SET WAS DISCARDED. DURING FOLLOW UP THE PATIENT'S PD NURSE REPORTED THAT THE PATIENT'S EFFLUENT REMAINED CLEAR. SHE DID NOT HAVE ANY SIGNS OF INFECTION. SHE WAS NOT TREATED WITH ANY ANTIBIOTIC. NO ADVERSE EVENT REPORTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407985 | LIBERTY CYCLER SET, DUAL PATIENT CONNECT | FKX | REYNOSA MANUFACTURING | 14BR8019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | LIBERTY CYCLER |