There was no patient involvement.The heater-cooler 16-02-82 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Field service technician dispatched to the facility confirmed the issue and solved it replacing patient pump.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The most likely root cause of the reported event is a corroded/damaged motor bearing, probably due to environmental condition, which prevented the motor shaft rotating.
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