MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-09-22 for FREEDOM CYCLER PD+ NA manufactured by Fresenius Medical Care North America.
[640398]
A home patient reported that he woke up feeling very full and distended during his ccpd treatment. He noticed that fluid was leaking around his catheter exit site. The cycler screen was blank. He tried to power it back on but was unable to. He drained manually and was able to fill three 3-liter bags to capacity. He felt relieved after. His fill volume is 3,000 ml. There was no serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2006-00007 |
| MDR Report Key | 875996 |
| Report Source | 04 |
| Date Received | 2006-09-22 |
| Date of Report | 2006-08-25 |
| Date of Event | 2006-08-25 |
| Report Date | 2006-08-25 |
| Date Mfgr Received | 2006-08-25 |
| Device Manufacturer Date | 2001-11-01 |
| Date Added to Maude | 2007-07-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELVY DIZON, BSN, RN, CNN |
| Manufacturer Street | 2637 SHADELANDS DRIVE |
| Manufacturer City | WALNUT CREEK CA 94598 |
| Manufacturer Country | US |
| Manufacturer Postal | 94598 |
| Manufacturer Phone | 9252950200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM CYCLER PD+ |
| Generic Name | PERITONEAL DIALYSIS CATHETER |
| Product Code | KPF |
| Date Received | 2006-09-22 |
| Returned To Mfg | 2006-09-05 |
| Model Number | PD+ |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 855576 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | * WALNUT CREEK CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-22 |