Device Dossier

Oxygenator, extracorporeal membrane

Device Dossier for Oxygenator, extracorporeal membrane (Oxygenator, extracorporeal membrane, Class IIa, sponsor Spectrum Medical). ARTG record, intended…

Intended purpose

The Quantum Perfusion Blood Oxygenator device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical and Extracorporeal Life Support (ECLS) procedures. Oxygen diffuses into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated arterial filter, or cardiotomy/venous reservoir. This is a single-use device.

TGA Public Summary