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).This event was initially considered to be non-reportable.However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).After procedure the unit was tested in the workshop of technical department of the hospital, where the fuses were blown.A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced it back to the compressor.Signs of corrosion were noticed on the cooling coils.The unit was recommended to be returned to livanova deutschland for further investigation and repair.After a follow-up communication, livanova was informed, that the customer replaced the claimed device with one from another manufacturer and that the device was scrapped so no further evaluation is possible.Corrective actions are in progress for this issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device was not returned.
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