A class action lawsuit has been filed against LivaNova over its Sorin 3T Heater-Cooler system. The suit, which represents two plaintiffs so far, alleges that the Sorin 3T Heater-Cooler introduced nontuberculous mycobacterium when the device was used during heart surgeries. The plaintiffs underwent these heart surgeries with the Sorin 3T at separate hospitals. The suit seeks to represent individuals who suffered an infection, allegedly due to the Sorin 3T Cardiac Heater-Cooler.
The Sorin 3T Heater-Cooler is used during heart surgeries to maintain the temperature of a patient’s organs and blood. The device uses a water tank containing temperature controlled water; this fluid does not make direct contact with patients. According to the U.S. Food and Drug Administration (FDA), however, contaminants from the water can be aerosolized, or transmitted through air.
In October 2015, the FDA issued a Safety Communication warning of nontuberculous mycobacterium infections associated with heater-cooler devices. The agency noted that “Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.” The agency said it received 32 reports of infections associated with heater-cooler devices between January 2010 and August 2015; 25 reports were submitted in 2015 alone.
Nontuberculous Mycobacteria (NTM) is normally found in the environment. In healthy individuals it is usually not harmful, but it can cause serious infection in people who are ill or who have weakened immune systems.
The FDA issued another Safety Communication in June 2016, this time specific to the Stӧckert 3T Heater-Cooler System (3T), manufactured by Sorin Group Deutschland GmbH (now known as LivaNova). According to the alert, a European study found that the Sorin 3T Heater-Coolers are associated with a risk of Mycobacterium chimaera (M. chimaera), a type of NTM. The findings indicate a direct link to the heater-coolers, the FDA said. The alert states, “The results of this paper suggest a direct link between the M. chimaera to which the European patients were exposed and became infected during open-chest cardiac surgery, and one specific heater-cooler model – the 3T.”
In October 2016, the FDA released another update, stating that the Stockert 3T Heater-Cooler was associated with M. chimaera infections in distinct geographic locations in the United States. The agency said whole genome sequencing was performed on samples taken from infected patients, water drained from the 3T and air samples collected while the 3T was being used. “Whole genome sequencing was completed on clinical isolates taken from infected patients and samples taken from 3T heater-cooler devices in hospitals where clusters of patient infections were identified. Samples of the water drained from the 3T devices and air samples collected while the devices were in operation were tested. The results strongly suggest the 3T heater-cooler units are the source of M. chimaera contamination.” the alert states.
Plaintiffs in the class action allege that LivaNova knew or should have known about the risk of infection associated with the 3T heater-cooler, and alleges the company failed to disclose this risk.