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 could confirm the reported error.He traced the fault back a patient pump which had a bearing damage.The pump was replaced and the issue solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The issue was most likely caused by environmental conditions in which the pumps operate.Water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase may led to bearing damage not allowing the pump the rotate freely.
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