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 and could confirm the reported issue.He noticed some liquid residues on the distributor board ul510 and damages on the ribbon cable connecting the distribution board and the cpu pcb.The technician replaced the parts and was thus able to remove the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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