NEXSYS PCS Adverse Event — Death (MDR 1219343-2020-00030)
NEXSYS PCS Adverse Event — Death (MDR 1219343-2020-00030) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NEXSYS PCS; Generic name: PCS-300-US; Manufacturer: HAEMONETICS CORPORATION.
| Device | NEXSYS PCS |
|---|---|
| Generic name | PCS-300-US |
| Manufacturer | HAEMONETICS CORPORATION |
| Report number | 1219343-2020-00030 |
| Event type | Death |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | PROCEDURE RAN AS EXPECTED WITHOUT COMPLICATIONS. THE FACILITY WAS INFORMED BY THE SON THAT THE DONOR DIED 5 DAYS LATER DUE TO A HEART ATTACK. A FIELD SERVICE ENGINEER WAS DISPATCHED AND INSPECTED THE PCS-300-US MACHINE. VERIFICATION SHEET WAS INSPECTED AND SHOWED ALL PARAMETERS WERE IN SPECIFICATION AND NO ADJUSTMENTS WERE NECESSARY. |
| Source | openFDA MAUDE (device adverse events) |
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