MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-01-11 for FREEDOM CYCLER PD+ PD+ IQCARD NA manufactured by Fresenius Medical Care-north America.
[569278]
A home peritoneal dialysis pt reported that he woke up around 3:30 a. M. With stomach discomfort during his ccpd treatment. He noticed that the solution bags were empty and the cycler screen was blank. He tried to power it back on, but was unable to restore power to the cycler. He removed the tubing from the lower valve box to drain the solution from his abdominal cavity. The drain amount is not known. Since he was not able to complete his treatment, it is estimated that he was filled with at least twice the amount of his fill volume.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2007-00001 |
| MDR Report Key | 810092 |
| Report Source | 04 |
| Date Received | 2007-01-11 |
| Date of Report | 2006-12-16 |
| Date of Event | 2006-12-16 |
| Date Facility Aware | 2006-12-16 |
| Report Date | 2006-12-16 |
| Date Reported to Mfgr | 2006-12-16 |
| Date Mfgr Received | 2006-12-16 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2007-01-31 |
| 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 | 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 | 2007-01-11 |
| Returned To Mfg | 2006-12-27 |
| Model Number | PD+ IQCARD |
| 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 | * |
| Device Sequence No | 1 |
| Device Event Key | 797576 |
| 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 | 2007-01-11 |