MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2005-10-25 for FREEDOM CYCLER PD+ PD+ IQCARD NA manufactured by Fresenius Medical Care North America.
[502174]
The pt's wife called to report that there was not enough fluid at the last fill. The pt uses three 5-liter solution bags for 5 or 6 fills. Pt was able to fill 1,650 ml of a 2,300 ml fill. She said the pt c/o bloating and there were some high drain volumes but the highest volume reported was around 3,000 ml. Which did not meet the manufacturer's criteria for an overfill. On 10/3/05, the manufacturer's failure analysis department reported that the cycler data sheets show a high drain volume that meets the criteria for an overfill. Review of the stored data sheets showed that drain 4 was 4,262 ml and fill 5 was only 1,581 ml.
Patient Sequence No: 1, Text Type: D, B5
[7834052]
Failure investigation is still in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2005-00014 |
| MDR Report Key | 755271 |
| Report Source | 04,05 |
| Date Received | 2005-10-25 |
| Date of Report | 2005-09-03 |
| Date of Event | 2005-09-02 |
| Report Date | 2005-09-03 |
| Date Reported to Mfgr | 2005-09-03 |
| Date Mfgr Received | 2005-09-03 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2006-08-30 |
| 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 | FREEDOM CYCLER PD+ |
| Generic Name | PERITONEAL DIALYSIS CYCLER |
| Product Code | KPF |
| Date Received | 2005-10-25 |
| Returned To Mfg | 2005-09-19 |
| Model Number | PD+ IQCARD |
| 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 | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 743090 |
| 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+ IQCARD |
| Baseline Catalog No | 180-60217 |
| 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 | 2005-10-25 |