There was no known 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) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).The laboratory report has been provided to livanova (b)(4).Livanova (b)(4) initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Corrective actions are in progress for this issue.
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