Patient information was not provided.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).(b)(4).A sorin group field service representative was dispatched to the facility to investigate.The service representative replaced the pump motor on the patient bridge, which was found during troubleshooting to be the cause of the reported issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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