MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-03-08 for PD+ CYCLER NEWTON IQ NA manufactured by Fresenius Medical Care North America.
[16821772]
The family member of a home ccpd patient reported that the pt ws overfilled during treatment. The pt was crying and c/o feeling very full. When they checked their stomach, they were very distended. The cycler was in dwell 2. They called tech. Support and was advised to drain the pt. The drain volume was 1,480 ml. The prescribed fill volume was 550 ml. There was no pt complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2005-00001 |
| MDR Report Key | 582926 |
| Report Source | 04 |
| Date Received | 2005-03-08 |
| Date of Report | 2005-02-13 |
| Date of Event | 2005-02-13 |
| Date Facility Aware | 2005-03-03 |
| Report Date | 2005-02-13 |
| Date Reported to Mfgr | 2005-02-13 |
| Date Mfgr Received | 2005-02-13 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2005-03-22 |
| 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 | 8002272572 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PD+ CYCLER |
| Generic Name | PERITONEAL DIALYSIS CYCLER |
| Product Code | KPF |
| Date Received | 2005-03-08 |
| Model Number | NEWTON IQ |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 572754 |
| 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 | 2005-03-08 |