A failure mode effect analysis on extracorporeal circuits for cardiopulmonary bypass.

Although many refinements in perfusion methodology and devices have been made, extracorporeal circulation remains a contributor to neurological complications, bleeding coagulopathies, use of blood products, as well as systemic inflammatory response. With the exposure of these adverse effects of cardiopulmonary bypass, the necessity to re-examine the safety of extracorporeal circuits is vital. A failure mode effect analysis (FMEA) is a proven proactive technique developed to evaluate system effect or equipment failure.