MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-01-06 for FREEDOM CYCLER PD+ NEWTON IQ NA manufactured by Fresenius Medical Care North America.
[20158119]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2004-00002 |
| MDR Report Key | 508393 |
| Report Source | 04 |
| Date Received | 2004-01-06 |
| Date of Report | 2003-11-18 |
| Date of Event | 2003-11-18 |
| Date Facility Aware | 2004-01-02 |
| Report Date | 2003-11-18 |
| Date Reported to Mfgr | 2003-11-18 |
| Date Mfgr Received | 2003-11-18 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2004-01-29 |
| 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 DR |
| 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 | 2004-01-06 |
| Returned To Mfg | 2003-12-01 |
| Model Number | NEWTON IQ |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 497339 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | 2637 SHADELANDS DR. WALNUT CREEK CA 94598 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 | 2004-01-06 |