FDA Adverse Event
Malfunction
Summary report: N
FREEDOM CYCLER PD+
MDR report key: 283534
·
Received June 22, 2000
Report
- Report Number
- 2937457-2000-00039
- Event Type
- Malfunction
- Date Received
- June 22, 2000
- Report Date
- June 5, 2000
- Manufacturer
- FRESENIUS MEDICAL CARE-NORTH AMERICA
- Product Code
- KPF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FAILURE INVESTIGATION OF A CYCLER RETURNED FOR A NON-REPORTABLE PROBLEM SHOWED THAT THE CYCLER DELIVERED INACCURATE FILL VOLUMES DURING SIMULATED TREATMENTS. THE MEASURED FILL VOLUME WAS APPROX 169% OF THE PROGRAMMED FILL VOLUME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEDOM CYCLER PD+ | PERITONEAL DIALYSIS CYCLER | KPF | FRESENIUS MEDICAL CARE-NORTH AMERICA | PD+ | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |