MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-11-10 for FREEDOM CYCLER PD+ NEWTON IQ NA manufactured by Fresenius Medical Care North America.
[539127]
A home peritoneal dialysis patient reported that the cycler was skipping to fill 1 without completing drain 0. The patient has a last fill of 2,000 ml. He did not have the details, i. E. , drain volumes. The cycler was replaced and the problem has not recurred. There was not enough information during initial contract to make an mdr determination. The cycler was received by the manufacturer on october 14, 2005. The data sheets which were retrived on october 27, 2005 show a drain 0 time of 2 minutes and a drain 0 volume of 30. Fill 1 was 2,000 ml. And drain 1 was 4,600 ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2005-00020 |
| MDR Report Key | 756474 |
| Report Source | 04 |
| Date Received | 2005-11-10 |
| Date of Report | 2005-09-30 |
| Date of Event | 2005-09-30 |
| Report Date | 2005-09-30 |
| Date Mfgr Received | 2005-09-30 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2006-09-05 |
| 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 | * |
| 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 | 2005-11-10 |
| Returned To Mfg | 2005-10-14 |
| Model Number | NEWTON IQ |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 744358 |
| 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 | NEWTON IQ |
| Baseline Catalog No | 180-60300 (NEW) |
| 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 | 2005-11-10 |