DEVICE: VitalFlow Set (10850007732339)

Device Description: The VitalFlow set contains components used to complete an extracorporeal circuit for ECMO procedures, including tubing assemblies, the Nautilus VF ECMO Oxygenator, and the VitalFlow Centrifugal Pump. The VitalFlow set contains a preassembled drainage and return loop “ECMO Circuit”, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The “Priming Circuit” contains components to supplement the basic extracorporeal circuit, as needed per hospital protocols for setting up the ECMO circuit. A venous reservoir and a one-way valve are included in the priming circuit to facilitate ease of priming the ECMO circuit. The Nautilus VF ECMO oxygenator with Balance Biosurface is used to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed. The VitalFlow Centrifugal Pump is designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. To limit friction and heat generation, the VitalFlow centrifugal pump utilizes a pivot bearing design on a dual ceramic pivot.