LIVANOVA INSPIRE 8FS Adverse Event — Malfunction (MDR 10004573)
LIVANOVA INSPIRE 8FS Adverse Event — Malfunction (MDR 10004573) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LIVANOVA INSPIRE 8FS; Generic name: OXYGENATOR, CARDIOPULMONARY BYPASS; Manufacturer: LIVANOVA USA, INC..
| Device | LIVANOVA INSPIRE 8FS |
|---|---|
| Generic name | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Manufacturer | LIVANOVA USA, INC. |
| Report number | 10004573 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | UPON INITIATION OF BYPASS A NOTICED A DROP OF BLOOD ON FLOOR BENEATH THE LIVA NOVA OXYGENATOR, ON TOWEL PLACED. IT DOES NOT IMPEDE THE FUNCTION OF THE OXYGENATOR, NOR DID IT AFFECT THE SURGERY OF THE PATIENT. LEAK SUBSIDED AND CASE CONTINUED WITH SUCCESS. |
| Source | openFDA MAUDE (device adverse events) |
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