Livanova deutschland manufactures the centrifugal pump 5 (cp5) drive unit.The incident occurred in (b)(6).Through follow-up communication, livanova learned that the cp5 stopped pumping during procedure after 1:30 hour and did not show any alarms.The customer had to switch it out with a centrifugal pump console (scpc) and it worked fine.Then the customer ran the cp5 for three hours after the case and it ran fine.Moreover, the facility said that the event was due to a user error: pressure settings were too low for the flow rate requested and therefore flow went to detent setting.Function verified corrected by biomed after setting pressure values to appropriate for four lpm flow.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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