Model Number 3ZZ*R4000C |
Device Problem
Device Issue (2379)
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Patient Problem
No Patient Involvement (2645)
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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).
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Event Description
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up, it appears to be glue on the attachment of the reservoir.No patient involvement.Product was 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 june 2, 2016.Method: actual device evaluated; visual inspection.Results: non-functional defect.Conclusions: human factors issue.The actual sample was returned for evaluation.During visual inspection, it was confirmed that excess dried bonding agent was on the tubing outside the connected port.No damages were present in the affected area of the product.The cause of the issue is that there was excess bonding agent on the tubing when it was inserted into the port.This is not a functional issue as the excess bonding agent does not cause any damage to the tubing or port.Review of the device history records revealed no manufacturing issues.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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