MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-02-27 for FREEDOM CYCLER PD+ PD+ IQCARD NA manufactured by Fresenius Medical Care - North America.
[286879]
A home peritoneal dialysis patient reported that the cycler gave fill alarms and the solution bags were empty. The cycler data sheets showed incomplete treatments and drain volumes>4 liters. The patient's prescribed fill volume is 2,7000 ml. The patient also c/o of feeling bloated during these treatments. There was no serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2003-00006 |
| MDR Report Key | 446018 |
| Report Source | 04 |
| Date Received | 2003-02-27 |
| Date of Report | 2003-01-31 |
| Date of Event | 2003-01-29 |
| Report Date | 2003-01-31 |
| Date Reported to Mfgr | 2003-01-31 |
| Date Mfgr Received | 2003-01-31 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2003-03-06 |
| 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 | 0 |
| 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 | 2003-02-27 |
| Returned To Mfg | 2003-02-10 |
| Model Number | PD+ IQCARD |
| 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 | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 434984 |
| 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 | 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 | 2003-02-27 |