MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-04-17 for FREEDOM CYCLER PD+ PD+ IQCARD NA manufactured by Fresenius Medical Care-north America.
[332045]
A nurse reported that a pt was overfilled with solution during a ccpd treatment. The machine alarmed about 45 mins after the treatment was started. The nurse was able to clear the alarm. Two hours later, the machine gave another alarm. The pt was c/o abdominal cramps and distention. The nurse noticed that the solution bags were almost empty. She bypassed to drain and was able to drain 1,500 ml. But the pt was still distended. She increased the drain time to 1. 5 hrs. And bypassed to another drain. When she returned, the drain volume shown was 10,050 ml. The pt felt relieved at this time. There was no serious injury or illness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2003-00011 |
| MDR Report Key | 455135 |
| Report Source | 05 |
| Date Received | 2003-04-17 |
| Date of Report | 2003-03-18 |
| Date of Event | 2003-03-17 |
| Date Facility Aware | 2003-03-17 |
| Report Date | 2003-03-18 |
| Date Reported to Mfgr | 2003-03-18 |
| Date Mfgr Received | 2003-03-18 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2003-04-23 |
| 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 DRIVE |
| 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 | 2003-04-17 |
| Model Number | PD+ IQCARD |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 444132 |
| 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 | 2003-04-17 |