Device Dossier

Cardiopulmonary bypass system heat exchanger, single-use

Device Dossier for Cardiopulmonary bypass system heat exchanger, single-use (Cardiopulmonary bypass system heat exchanger, single-use, Class IIa, sponsor…

Intended purpose

The Quantum PureFlow Heat Exchanger is intended to heat/cool blood or cardioplegic solutions for periods lasting up to 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for surgical procedures. For applicable codes contact with cardioplegic solution for longer than this period is not permitted.

TGA Public Summary