Sorin group (b)(4) has received a report that, 30 minutes after the bypass was begun, a leak near the temperature port of the inspire 6 oxygenator was identified.The medical team elected to change out the oxygenator.The change out took 5 minutes.The procedure was completed with no issue.There is not report of any patient injury.
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H.10 sorin group italia manufactures the inspire 6 phisio oxygenator.The incident occurred in newport news, virginia (united states).The complained oxygenator was returned to livanova for investigation.Leak test confirmed the leak between the polycarbonate holder of the temperature probe and its metallic pin.Dhr verification did not reveal any relevant information possibly linked with the claimed defect.Based on complaints review, the reported issue is not related to a specific lot nor oxygenator model related.Livanova investigation suggested the most probable root cause of the claimed leak is a delamination between the metal pin and the co-molded polycarbonate holder.Such a partial detachment caused a leakage path through the metal-plastic interface.According to investigation, this leak is not detectable during the in-process leak tests performed on 100% of inspire oxygenator units during manufacturing.The leak is triggered and enhanced by subsequent stresses such as sterilization and shipping stresses.The frequency of this type of event is low (remote).To further reduce the occurrence of this type of event, as part of continuous improvement project, n additional in-line leak testing of the temperature probe has been validated and implemented during the co-molding process at supplier site on december 2019.The unit involved in the present complaint was manufactured before the implementation of the above described improving action.Livanova will keep monitoring the market.
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