FDA Adverse Event
Malfunction
Summary report: N
FREEDOM CYCLER PD+
MDR report key: 272984
·
Received April 7, 2000
Report
- Report Number
- 2937457-2000-00019
- Event Type
- Malfunction
- Date Received
- April 7, 2000
- Report Date
- December 27, 1999
- Manufacturer
- FRESENIUS MEDICAL CARE-NORTH AMERICA
- Product Code
- KPF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A HOME PERITONEAL DIALYSIS PT REPORTED THAT THE CYCLER GAVE AN ALARM AND PT RAN OUT OF SOLUTION DURING THE TREATMENT. PT DID NOT REMEMBER WHAT TYPE OF ALARM OR IN WHICH CYCLE. PT FELT A LITTLE DISCOMFORT BUT DID NOT NOTICE ANY UNUSUALLY HIGH DRAIN VOLUMES. PT DID NOTICE SOME FILL VOLUMES THAT WERE HIGH (AROUND 2,300ML). THE PRESCRIBED FILL VOLUME WAS 1,700ML. THESE DID NOT MEET THE MFR'S CRITERIA FOR A REPORTABLE OVERFILL. WHEN THE CYCLE WAS RECEIVED FOR FAILURE INVESTIGATION, THE DATA SHEET WAS RETRIEVED AND THE FILL VOLUMES SHOWN WERE 3,310 AND 3,320ML. THESE ARE HIGHER THAN THE INITIAL REPORTED VOLUMES. THE DRAIN VOLUMES WERE CONSISTENT WITH THE FILL VOLUMES. THE HIGHEST DRAIN VOLUME WAS APPROXIMATELY 210% OF THE PRESCRIBED 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 | 72 YR |