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).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported failure and noted an error code on patient circuit 2.The level sensor was checked and re-positioned.Through further troubleshooting, the fault was traced to the cpu distributor connector, which was out of alignment.The alignment was corrected and a functional test was performed without further issues.The device was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device not returned.
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