MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-02-15 for FREEDOM CYCLER PD+ NA manufactured by Fresenius Medical Care- North America.
[15186931]
The stored data sheets of a cycler that was returned to the manufacturer were retrieved in 2006. A large drain volume of 3,281 ml was noted in one of the ccpd treatments. This drain volume is 182% of the prescribed fill volume of 1,800 ml. The patient had called in 11/05 stating that she was running out of fluid and wanted to known the possible causes. Patient was contacted and reported no serious injury or complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2006-00002 |
| MDR Report Key | 679297 |
| Report Source | 04 |
| Date Received | 2006-02-15 |
| Date of Report | 2005-11-23 |
| Date of Event | 2005-11-21 |
| Report Date | 2005-11-23 |
| Date Reported to Mfgr | 2005-11-23 |
| Date Mfgr Received | 2005-11-23 |
| Device Manufacturer Date | 2002-04-01 |
| Date Added to Maude | 2006-02-28 |
| 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 CYCLER |
| Product Code | KPF |
| Date Received | 2006-02-15 |
| Returned To Mfg | 2006-01-24 |
| Model Number | PD+ |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 668559 |
| Manufacturer | FRESENIUS MEDICAL CARE- NORTH AMERICA |
| Manufacturer Address | * WALNUT CREEK CA * US |
| Baseline Brand Name | FREEDOM CYCLER PD+ |
| Baseline Generic Name | PERITONEAL DIALYSIS CYCLER |
| Baseline Model No | PD+ |
| Baseline Catalog No | 180-60200 |
| Baseline ID | NONE |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K915634 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-15 |