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A Louisiana couple indicates that their minor daughter contracted a serious hospital infection due to a contaminated 3T Heater Cooler system used during open heart surgery.
In a complaint (PDF) filed last week in the U.S. District Court for the Eastern District of Louisiana, Amando Cuellar and Aleyda Romero indicate that tainted systems used to control blood temperature during cardiac surgery exposed their daughter to bacteria which has been linked to reports of similar infections that may surface months or even years later.
The minor child, Valentina Cuellar, underwent open heart surgery in August and September of 2017, at which time a 3T Heater-Cooler was used. Following the procedures, she contracted, and was treated for, mycobacterium abscessus and staphylococcus aureus infections.
According to allegations raised in the lawsuit, Livanova knew for several years about the risk of contamination with it’s 3T Heater-Cooler systems, but failed to provide adequate warnings or take effective actions to address the problem.
“Upon information and belief, by April 2015, [the manufacturer] knew that their ‘enhanced hygiene concept’ was ineffective in eliminating all bacteria, including mycobacteria chimaera, from devices that were not new and/or were already contaminated,” according to the complaint.
The Cuellars raise allegations similar to those presented in dozens of other surgical infection lawsuits filed by individuals nationwide, which claim that devices release contaminated bacteria in a mist into the air of the operating room, which may enter the open surgical wound.
Valentina Cuellar was one of several children diagnosed with infections at the Louisiana Children’s Medical Center, after undergoing heart surgery involving the 3T Heater-Cooler system, according to the lawsuit.
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.
Given similar questions of fact and law presented in lawsuits filed nationwide, the dozens of cases filed throughout the federal court system have been centralized as part of a multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.