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 found some residues on the display board possibly due to water ingress.The leakage was caused by the yellow plugs of the mixing block on the cardioplegia bridge.He replaced the yellow plugs and the display board and the issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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