Sorin group (b)(4) manufactures the s5 gas blender system.The incident occured in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) requested return of the device for detailed investigation.However, due to the cost associated with the repair, the customer decided to not return the device to sorin group (b)(4) and the unit was removed from service.As the device was not returned, an investigation could not be performed and a root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Device retained by customer.
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