On february 09, 2023, livanova was informed that root cause was a low water level into the tank.Accordingly, as soon as the water level was restored, the system cooled properly.The low water level was identified after the case.According to 3t heater cooler ifu, the tanks must be re-filled in the case the water level is below the threshold.The event has been reassessed to not reportable event since the issue was solely caused by user error without any patient impact.A device service history review was performed and identified that the heater cooler unit was installed since 2016 and no similar events were reported.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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