There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6), usa.The defective part has been investigated.The described error could be reproduced.The origin of the failure is was a blocked mechanism, whereas the root cause of this blocked mechanism remails unknown.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|