MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-05 for LIBERTY CYCLER manufactured by Fresenius.
[2448694]
Problem with peritoneal dialysis cycler malfunctioning. Overfilling patient to the point of discomfort for unknown reason. Unable to resolve problem per technical support. Discontinued product use, unsafe to continue use of product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023363 |
| MDR Report Key | 2364335 |
| Date Received | 2011-12-05 |
| Date of Report | 2011-12-05 |
| Date of Event | 2011-11-22 |
| Date Added to Maude | 2011-12-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBERTY CYCLER |
| Generic Name | PERITONEAL DIALYSIS CYCLER |
| Product Code | KPF |
| Date Received | 2011-12-05 |
| Model Number | LIBERTY CYCLER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-12-05 |