QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.

It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped.

Maquet sent a Field Safety Notices and Confirmation Forms dated June 13, 2012 to all affected customers. A Follow-up communication dated July 20, 2012 was mailed to all affected US customers. The Field Safety Notice identifies the problem, affected product, risk factors and actions to be taken by the customer. Customers were instructed to complete the Confirmation form and return in the self-addressed prepaid envelop. For questions call 201-995-8968. Maquet issued an updated Field Safety Notice/Field Safety Notice Confirmation Form dated 2/14/13 via Fed Ex on 2/18/2013. Maquet sent out an Updated Field Safety Notice/field Safety Notice Confirmation Form dated 4/4/2013 in order to notify customers they would be providing safety clamps.