Sorin group (b)(4) manufactures the s5 gas blender system.The incident occured in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 gas blender alarmed repeatedly during setup.Investigation of the returned gas blender confirmed the reported issue.A defective mass flow controller for co2 caused the problem.The part was replaced.Testing, calibration and safety inspections were performed with no deviations.A review of the device history record did not find any concessions, deviations or non-conformities related to the reported failure.The issue will be monitored for trends and if identified, corrections will be recommended.
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