The mother of a young girl who suffered a nontuberculosis mycobacteria (NTM) infection following heart surgery alleges that the sternal infection was caused by a contaminated 3T Heater-Cooler system used during the procedure.
Magaley De La Cruz filed a complaint (PDF) against Sorin Group and Liva Nova PLC in the U.S. District Court for the Eastern District of Louisiana on June 25, on behalf of herself and her minor daughter, Genesis De La Cruz.
According to the lawsuit, Genesis underwent a bilateral branch pulmonary arterioplasty procedure in June 2017, at Children’s Hospital in New Orleans. During the procedure, a 3T heater cooler system was used to regulate the temperature of her blood, which the lawsuit resulted in her developing a sternal infection.
In August 2017, De La Cruz and her daughter told a pediatric cardiologist that Genesis was suffering pain, swelling and tenderness around her incision site. She was diagnosed with a NTM sternal wound infection and placed in the children’s intensive care unit (CICU).
“Cultures returned with positive findings of an m. abscessus infection and a rigorous course of antibiotics were instituted, including Zyvox, Zithromax, and Amikacin,” the lawsuit states. “Moreover, wound vac was placed on August 13th and a peripheral IV was placed on August 17th. On or about August 29th, a left internal jugular broviac central line catheter was placed due to the need for long-term IV access.”
Genesis was hospitalized from August 10, 2017, until October 10, 2017. Once she was released she still had to undergo an antibiotic regimen until early March 2018, the lawsuit states.
The claim is one of a growing number of 3T Heater Cooler lawsuits filed in federal courts nationwide, each raising similar allegations that units shipped worldwide were contaminated with NTM bacteria, resulting in patient infections.
Litigation over the Sorin 3T Heater-Cooler systems has emerged after it was discovered that certain devices sold in recent years may have contaminated sterile operating rooms.
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.