There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova service representative was dispatched to the hospital and confirmed that the cp5 drive head appeared to have water damages.The affected cp5 drive unit was requested back to livanova (b)(4) for investigation.During the internal visual inspection it was confirmed that several components were affected by dried fluid residuals and oxidation, which made any electrical test impossible.As root cause fluid/moisture ingress was determined, due to an improper handling by the customer.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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