There was no known patient involvement.The centrifugal pump system with tubing clamp 60-01-00 is not distributed in the usa and it is similar to centrifugal pump system with tubing clamp 60-02-15, which is distributed in the usa (510(k) number: k032213).Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to the motor control board which was replaced to solve the reported failure.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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