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).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)., through follow up attempts, additional information have not been received to complete investigation.The status of the device is unknown.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova (b)(4) will close this case at this point of time, but in case any additional information pertinent to the reported will be received, it will be provided in a supplemental report.Device not returned.
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