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 service representative was able to confirm the reported issue and traced the failure to a defective patient pump.The technician replaced the pump to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The pump was returned for further investigation.During the evaluation the pump motor housing has been removed.It was observed that the pump motor had bearing damage and the mounting was rusted.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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