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 field service technician was dispatched to the facility to investigate and replaced the distribution board as first attempt which was unsuccessful.During the troubleshooting he noticed that the motors on the patient site could be turned freely by hand.He then connected the patient motors on the cardioplegia site on the distribution board and they were working fine.A cpu board and the ribbon cable were replaced as second attempt.The problem could not be solved.It is likely that the failures were caused by the stirrer motor thus, a new one has been ordered.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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