The heater-cooler surgical devices, designed to control the temperature of a patient’s blood and organs during heart bypass surgery, have been linked to a host of bacterial infections. Research presented this June at the 44th Annual Conference of Association for Professionals in Infection Control and Epidemiology found potentially deadly Mycobacterium chimaera contamination in 37 percent of the units examined between June 2015 and December 2016. In addition, the study found other non-tuberculous mycobacteria, Legionella, and fungi.
In October 2016, both the Centers for Disease Control and the Food and Drug Administration specifically warned about the risks to patients posed by the use of Stockert 3T heater-cooler devices during surgery. The FDA blocked imports of the heater-cooler devices at the time. Studies warning of the risk of infection and safety communications regarding use of the heater-cooler devices, however, date back 15 years to 2002.
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Stockert 3T lawsuits arising from the infections at the New Orleans Children's Hospital could potentially target both the manufacturer for negligent design or production of the devices and the hospital, for professional malpractice, since it had notice of the risk of infection and the need for careful decontamination long before the surgeries occurred. If the parents choose to litigate, these lawsuits will join a host of other Stockert 3T infection lawsuits now pending in in the U.S. and Canada, some of which seek class action certification.