There was no patient involvement.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.He replaced the stirrer motor and the problem could be 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 issue was a bearing damage due to degradation.The causes leading to the corrosion, which generates irregularities on the surface of the balls, are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.
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