Centrifugal pump failures.

Centrifugal pumps will not pass gross quantities of gaseous emboli due to the nonocclusive nature of the pump. However, retrograde flow can occur under circumstances that include: product malfunctions, low flows, and human errors. Negative pressure created by falling arterial perfusate can draw air into the cannula. Food and Drug Administration (FDA) records about centrifugal pump malfunctions were obtained. Out of 350,000 cases completed with centrifugal pumps over a 23 month period, the FDA received reports of 68 malfunctions, 22 electrical burning smells, and three speed surges, yielding a failure rate of 1 in 3,763 cases. FDA records revealed five death reports and three serious injury reports. A survey was sent to 2,424 Society of Thoracic Surgeons' members to obtain more information; 285 who use centrifugal pumps responded. Sixty surgeons (21%) reported 108 malfunctions, including 46 complete pump failures. Fifty-one of 243 surgeons (21%) who use centrifugal pumps for bypass reported that perfusionists have forgotten to clamp the pump line, resulting in backflow. We conclude centrifugal pumps are generally safe, but malfunctions, low flows, and human errors can lead to retrograde flow and occasionally air embolization. There are valves that can be added to the bypass circuitry to prevent this risk.