FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER
MDR report key: 1821418
·
Received August 26, 2010
Report
- Report Number
- 2937457-2010-00009
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- July 24, 2010
- Report Date
- July 27, 2010
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A HOME PERITONEAL DIALYSIS PT REPORTED THAT SHE FELT BLOATED DURING HER CCPD TREATMENT. THE TREATMENT DATA SHOWED THAT THERE WERE DRAIN VOLUMES OF 4,417 ML AND 5,782 ML. ALARM HISTORY SHOWED MULTIPLE ALARMS. HER PRESCRIBED FILL VOLUME IS 2,500 ML. THE CYCLER WAS REPLACED AND THE PROBLEM HAS NOT REOCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTY CYCLER | PERITONEAL DIALYSIS CYCLER | FKX | FRESENIUS MEDICAL CARE NORTH AMERICA | LIBERTY | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |