A contaminated heater-cooler commonly used during open heart surgery allegedly caused a New Mexico man to suffer a fatal infection, according to allegations raised in a wrongful death lawsuit filed earlier this month against Sorin Group, the manufacturer of the device.
The complaint (PDF) was filed by Danna Brackenbury in the U.S. District Court for Minnesota earlier this month, indicating that her husband, Terrance, died of multisystem organ failure an septic shock in September 2016, after exposure to a 3T Heater-Cooler used during open heart surgery in April 2015.
Terrance Lee Brackenbury developed an M. chimaera infection after undergoing coronary artery bypass grafting, aortic valve replacement and ascending aortic aneurysm repair folowing a heart attack while working out at a gym.
The 3T Heater-Cooler is a device commonly found in operating rooms nationwide, which is used to regulate blood temperature during surgery. However, according to allegations raised in the lawsuit, as well as similar claims brought on behalf of individuals nationwide who suffered an infection after open heart surgery, certain devices manufactured by Sorin Group release a contaminated mist into the air of the operating room.
“Mr. Brackenbury contracted the M. chimaera infection, which ultimately led to his illness and death, because the bacteria reached the surgical site near Mr. Brackenbury’s sternum,” the lawsuit explains. “This occurred because the bacteria from the Sorin 3T became aerosolized during his procedure, fluid leakage occurred, by other means, and/or by some combination thereof.”
The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
Late last year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.
The complaint filed by Brackenbury’s wife is one of a growing number of other open heart surgery infection lawsuits filed nationwide over the 3T Heater-Cooler, alleging that the manufacturers knew about the risk of contamination and failed to adequately warn the medical community, the FDA, and patients of the risks.