Model Number 3CX*FX15RE30C |
Device Problem
Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Terumo has received the device for evaluation, however, 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.(b)(4).Results pending completion of investigation; conclusion not yet available.
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the adapters were missing.No patient involvement.The product was not changed out.Procedure was completed successfully.
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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 october 5, 2020.The sample was returned and evaluated, and was verified that bags of adapters were missing.Retention was reviewed and found to contain the bag of adapters.The quantity and presence of the adapters is verified 100% by manufacturing.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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Search Alerts/Recalls
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