Model Number 3CX*FX15RW40C |
Device Problem
Dent in Material (2526)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, they found a dented venous inlet port after it was removed from the packaging.No patient involvement.
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Manufacturer Narrative
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This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on january 02, 2024.The affected sample was not returned for evaluation; however, a photo was provided that confirmed the damage to the venous inlet port.A representative retention sample was inspected for damage with no damage noted on the device.All capiox units are 100% visually inspected at several points in the production process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Event Description
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Dented venous inlet port.
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Search Alerts/Recalls
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