There was no patient involvement.Livanova (b)(4) manufactures the s5 double head pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and he could confirm the reported failure.He replaced the computer board of the pump and the issue was solved.Functional verification testing was completed without further issues and the unit was returned to service.Livanova (b)(4) requested the board for a detailed investigation but it was not made available since the customer scrapped it.Thus, the exact root cause could not be identified.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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