MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-31 for LIBERTY SELECT CYCLER 180343 manufactured by Fresenius.
| Report Number | 8671129 |
| MDR Report Key | 8671129 |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-04-29 |
| Date Facility Aware | 2019-05-17 |
| Report Date | 2019-05-30 |
| Date Reported to FDA | 2019-05-30 |
| Date Reported to Mfgr | 2019-05-30 |
| Date Added to Maude | 2019-06-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBERTY SELECT CYCLER |
| Generic Name | PERITONEAL DIALYSIS CYCLER |
| Product Code | FKO |
| Date Received | 2019-05-31 |
| Model Number | 180343 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS |
| Manufacturer Address | CONCORD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Death | 2019-05-31 |