Model Number CONNECTOR |
Device Problem
Flare or Flash (2942)
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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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A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova usa has received reports of y connectors presenting a film inside one of y limbs.The issue occurred at setup, prior to any patient involvement.
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Manufacturer Narrative
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Livanova usa has received reports of wyes connectors presenting a film inside one of y limbs.Visual inspection of the interior of two returned wyes connectors found to have flash inside due to a molding partially occluding one branch of each connector.The exterior of both connectors did not show any damage or defects.Simulated high flow test performed with both returned connectors confirmed the flow through the occluded branches was restricted and turbulent.The occluding material did not detach.A review of the dhr did not identify any deviation relevant to the reported issue.No other similar complaint has been received for the claimed lot.The investigation confirmed the reported event: the wyes connectors were found to have flash due to molding.The health hazard evaluation assessed the residual risk resulted acceptable.This type of wye connectors is supplied to livanova by supplier.The supplier has been informed of the issue.Livanova will keep monitoring the market.
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Event Description
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See initial report.
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Search Alerts/Recalls
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