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Following heart surgery to implant a left ventricular assist device (LVAD), an Iowa man indicates that he developed a severe M. Chimaera infection from a 3T Heater-Cooler used to control blood temperature during open heart surgery.
The complaint (PDF) was filed by Matthew Adams U.S. District Court for the Southern District of Iowa on June 30, indicating that the heater-cooler manufactured by Livanova and Sorin Group released contaminated vapor into the operating room, which entered the sterile surgical field causing his infection.
Adams underwent LVAD surgery in June 2015, having the device placed to work as a mechanical blood pump while he awaited heart transplant surgery. Due to complications that lead to heart failure, Adams had the LVAD replaced about a month later.
Each of the procedures involved the use of a 3T Heater Cooler system, which is commonly used during open heart surgery to regulate the temperature of his blood. However, contaminated heater-cooler devices have been linked to reports of severe and life-threatening infections worldwide, which may not surface until months, or even years, after exposure to the contaminated vapors released by the device.
About three months after his LVAD surgery, in October 2015, Adams reported suffering from fatigue, joint pain, drenching night sweats, weight loss, fever and pain at the surgical site. Doctors then began testing him for nontuberculous mycobacterium (NTM) infections, of which M. Chimaera is one type. It would take months to confirm his infection.
As a result of the infection following LVAD surgery, Adams has required extensive treatment and his heart transplant has been delayed, as health care professionals fear that the new heart would be prone to contracting the infection if it is not defeated before the transplant surgery.
In February 2016, the hospital where Adams had his procedure, University of Iowa Hospitals and Clinics (UIHC), sent a warning letter to about 1,500 patients who underwent major heart, lung and liver surgery over the previous four years, indicating that they may have been exposed to contaminated heater-cooler systems.
Similar hospital warning letters to heart surgery patients have been sent by hospitals in at least 14 other states as well.
According to allegations raised in the heart surgery infection lawsuit filed by Adams, manufacturers of the 3T Heater Cooler System failed to take adequate steps to ensure their devices were free of contamination. The complaint also notes that the manufacturers knew about the potential risks for years without warning medical professionals or taking steps to prevent the problem.
“In April 2011 the FDA visited Defendant, Sorin, in Munchen, Germany for a plant inspection and to discuss safety concerns with several products, including the 3T approved in 2005 through the 510(k) process. The FDA advised the company that its 3Ts harbored dangerous bacteria and that it had failed to make a proper risk assessment for cleaning the devices to avoid bacterial infections in patients exposed in the operating room,” the lawsuit states. “During this inspection, the FDA advised the company that the bacterial growth charts it used to justify the original instruction for device disinfection every 14 days allowed bacterial overgrowth well in excess of safe standards in just one and a half days. The company admitted to the FDA that its cleaning instructions did not meet these standards and that it had no information to support the cleaning methods it disseminated to U.S. purchasers.”
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 is one of a growing number of other NTM 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.