FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./ECT. DL
MDR report key: 4551397
·
Received February 25, 2015
Report
- Report Number
- 8030665-2015-00102
- Event Type
- Malfunction
- Date Received
- February 25, 2015
- Date of Event
- January 29, 2015
- Report Date
- January 29, 2015
- Manufacturer
- REYNOSA MFG
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME. A SUPPLEMENTAL REPORT WIL LBE SUBMITTED UPON COMPLETION OF THE PLANT¿S INVESTIGATION.
Description of Event or Problem · 1
A PERITONEAL DIALYSIS (PD) CLINIC MGR REPORTED A FLUID LEAK FOLLOWING THE PT¿S DISCONTINUED TREATMENT. AFTER RECEIVING A CYCLER WARNING THE CLINIC MGR DISCOVERED FLUID LEAKING FROM THE CASSETTE DOOR. THE SAMPLES HAS BEEN RETAINED FOR EVAL. DURING FOLLOW UP, THE ATTENDING PD NURSE REPORTED THAT THE PT REMAINED ASYMPTOMATIC. HE DID NOT HAVE SIGNS OF INFECTION. HE WAS NOT PRESCRIBED PROPHYLACTIC ANTIBIOTICS. NO ADVERSE EVENT REPORTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132379 | LIBERTY CYCLER SET, SINGLE CONN./ECT. DL | FKX | REYNOSA MFG | 14KR08091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | PD SOLUTION,| LIBERTY CYCLER,| BYSTOLIC 10MG PER DAY |