There was no patient involvement.Device has not been returned to sorin group (b)(4).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).Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the sorin heater-cooler system 3t turned off during a routine disinfection cycle and could not be restarted.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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