Oxygenator, Long Term Support Greater Than 6 Hours

NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood t

May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer

NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood

May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer