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.
[2315944]
Liberty peritoneal cycler infusing incorrect volume into patient's abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023362 |
| MDR Report Key | 2364331 |
| Date Received | 2011-12-05 |
| Date of Report | 2011-12-05 |
| Date of Event | 2011-11-15 |
| 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 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2011-12-05 |