There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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 could confirm the reported issue.He found that the stirrer motor was blocked.He replaced the part and also the distribution board.The issue could be solved.Functional verification testing was completed without further issues and the unit was returned to service.Through follow-up communication livanova (b)(4) learned that the bearing of the stirrer motor was corroded and this likely caused the reported event.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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