The family of a Pennsylvania has filed a wrongful death lawsuit over a heart surgery infection caused by Sorin Heater-Cooler, indicating that the water tanks used by the device released a contaminated mist into the operating room during an aortic valve procedure.
The complaint (PDF) was filed late last month by the widow and children of Dennis L. Gerace, Sr., in the Superior Court of Delaware, against the manufacturer of the Sorin Heater-Cooler, as well as the hospital where the heart surgery was performed.
Gerace underwent heart surgery in October 2015, to repair a bicuspid aortic valve. During the procedure, a Sorin 3T heater-cooler device (HCD) was used to regulate the temperature of Gerace’s blood. However, it appears that the device was one of a number of contaminated surgical heater-coolers distributed to hospitals nationwide, which have been linked to reports of nontuberculous mycobacterium (“NTM”) infections at hospitals nationwide, often not surfacing until months or even years after exposure to the mist released by the device.
The complaint indicates that Gerace began experiencing what he thought were cold symptoms in May 2016, which continued to worsen. In June 2016, he went to Christiana Hospital, where at first it was suspected that he suffered from endocarditis and kidney failure. However, echocardiograms revealed “vegetation on the aortic valve and pacemaker lead,” as well as an aortic valve abscess. He was referred to infectious disease doctors, who determined in August 2016 that he was suffering from a mycobacterium chimaera, or M. chimaera, infection.
Although he was placed on aggressive and powerful antibiotics, Gerace failed to improve and eventually suffered worsening respiratory failure, kidney failure, oliguria and metabolic acidosis. As a result of the heart surgery infection, Gerace died in November 2016, due to M. chimaera sepsis and endocarditis.
Allegations raised in the Sorin 3T Heater-Cooler wrongful death lawsuit are similar to those presented in a number of other product liability complaints filed in courts nationwide, indicating that the manufacturer is responsible for distributing a medical device contaminated with potentially deadly bacteria to hospitals nationwide, and failing to warn the medical community, the FDA, and patients of the risks.
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.