There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).The affected part was requested to be returned to livanova (b)(4) for a detailed investigation but the part was not made available.Through follow-up communication with the technician in charge, livanova (b)(4) learned that, according to the customer, the issue did not re-occur.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.
|