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)(4).A livanova field service representative was dispatched to the facility to perform maintenance, during which he found noticed the degradation of the plug on the cardioplegia sub-assembly.The service representative replaced the plugs.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Corrective actions are in place to address this issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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