LIBERTY SELECT CYCLER ASSY(NON-VALUATED) Adverse Event — Death (MDR 2937457-2020-00747)
LIBERTY SELECT CYCLER ASSY(NON-VALUATED) Adverse Event — Death (MDR 2937457-2020-00747) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LIBERTY SELECT CYCLER ASSY(NON-VALUATED); Generic name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY; Manufacturer: CONCORD MANUFACTURING.
| Device | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) |
|---|---|
| Generic name | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
| Manufacturer | CONCORD MANUFACTURING |
| Report number | 2937457-2020-00747 |
| Event type | Death |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | CLINICAL REVIEW: THERE IS A TEMPORAL RELATIONSHIP BETWEEN PD THERAPY UTILIZING THE LIBERTY SELECT CYCLER AND THE REPORTED PATIENT DEATH DURING TREATMENT. HOWEVER, THERE IS NO DOCUMENTATION IN THE COMPLAINT FILE TO SHOW A CAUSAL RELATIONSHIP BETWEEN USE OF THE LIBERTY SELECT CYCLER AND THE PATIENT DEATH. ADDITIONALLY, THERE IS NO ALLEGATION OF A DEVICE MALFUNCTION OR DEFICIENCY REPORTED FOR THE DEA |
| Source | openFDA MAUDE (device adverse events) |
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