FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER
MDR report key: 4163620
·
Received July 17, 2014
Report
- Report Number
- 2937457-2014-01666
- Event Type
- Malfunction
- Date Received
- July 17, 2014
- Date of Event
- April 25, 2014
- Report Date
- June 19, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
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 PATIENT CALLED TECH SUPPORT WITH QUESTIONS ABOUT UF AMOUNTS. A FOLLOW UP CALL WAS MADE TO THE PATIENT'S PERITONEAL DIALYSIS NURSE. THE PATIENT'S NURSE REPORTED THAT PATIENT HAD UNDER GONE A SURGICAL HERNIA REPAIR ON (B)(6)2014. THE NURSE NOTED THAT THE PATIENT TENDS TO BE NON COMPLIANT WITH HER TREATMENTS. THE PATIENT WAS ON HEMO-DIALYSIS FOLLOWING HER SURGERY, AND RESUMED PERITONEAL DIALYSIS ON (B)(6)2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419054 | LIBERTY CYCLER | FKX | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | PD SOLUTION| LIBERTY TUBING |