There was no patient involvement.The heater-cooler 16-02-80 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).A livanova field service representative was dispatched to the facility to investigate the device and confirmed the reported issue.The stirrer motor was replaced and the issue solved.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 was the corrosion of the stirrer head due to condensation or high temperatures and high level of humidity in the stationary phase that led to the stop of the stirrer mechanism.
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