CAPIOX FX05 Adverse Event — Malfunction (MDR 9681834-2020-00062)
CAPIOX FX05 Adverse Event — Malfunction (MDR 9681834-2020-00062) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CAPIOX FX05; Generic name: OXYGENATOR, CARDIOPULMONARY BYPASS; Manufacturer: TERUMO CORPORATION, ASHITAKA.
| Device | CAPIOX FX05 |
|---|---|
| Generic name | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Manufacturer | TERUMO CORPORATION, ASHITAKA |
| Report number | 9681834-2020-00062 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D10, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION, AS WELL AS A MOVIE PROVIDED BY THE USER. REVIEW OF THE MOVIE CONFIRMED THE LEAKAGE FROM THE JOINT OF THE RESERVOIR OUTLET PORT AND THE ADAPTOR. THE TUBE FROM THE ADAPTOR SEEMED CURVE |
| Source | openFDA MAUDE (device adverse events) |
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