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A contaminated 3T Heater-Cooler, which is commonly used to control blood temperature during open heart surgery, allegedly caused a Florida man to develop a severe M. Abscessus infection following a mitral valve replacement and double bypass procedure.
The family of Hector Batista filed a product liability complaint (PDF) in the U.S. District Court for the Southern District of Florida on July 21, indicating that Livanova PLC and Sorin Group sold an unreasonably dangerous and defective system, which is prone to colonize bacteria that is then transmitted to patients during invasive surgery.
Batista underwent the open heart surgery in July 2013, at which time a 3T Heater-Cooler was used to regulate his blood temperature. In December 2013, Batista had a left ventricular assist device (LVAD) implanted as a bridge to a heart transplant, but had to have the device replaced in September 2015, after he was diagnosed with an M. Abscessus infection.
In February 2016, Batista underwent a heart transplant, but was still infected, and the infection made its way to the heart tissue. As a result, he required about a year of IV antibiotic treatment.
Months later, in November 2016, Batista received a letter from the hospital where he underwent the open heart surgery, indicating that he may have been exposed to a contaminated 3T Heater-Cooler System.
Similar hospital warning letters to heart surgery patients have been sent by other facilities nationwide, after it was discovered that problems with the 3T Heater-Cooler System were causing the heart surgery infections.
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 Batista’s family 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.