FDA Adverse Event
Malfunction
Summary report: N
FREEDOM CYCLER PD+
MDR report key: 508393
·
Received January 6, 2004
Report
- Report Number
- 2937457-2004-00002
- Event Type
- Malfunction
- Date Received
- January 6, 2004
- Date of Event
- November 18, 2003
- Report Date
- November 18, 2003
- 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
THE CYCLER WAS SKIPPING CYCLES AND THERE WAS NO INDICATION OF AN OVERFILL. ADD'L INFO RECEIVED IN 2003 INDICATED THAT THE PT'S WEIGHT SHOWED AN INCREASE OF 13 LBS. AFTER THEIR CCPD TREATMENT. ANOTHER TIME, THEY FELT VERY BLOATED AND NOTICED THAT THEIR CATHETER SITE WAS LEAKING. THEY STOPPED TREATMENT AND DRAINED MANUALLY. THEY DRAINED ABOUT 4,000-4,200ML. IN A DRAIN BAG AND ABOUT 500ML. MORE IN ANOTHER. THEIR PRESCRIBED FILL VOLUME IS 2,000ML. NO MEDICAL INTERVENTION WAS NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEDOM CYCLER PD+ | PERITONEAL DIALYSIS CYCLER | KPF | FRESENIUS MEDICAL CARE NORTH AMERICA | NEWTON IQ | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |