Stockert Heater-Cooler System (3T) is manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) and provides temperature-controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less. It is a Class II medical device which was approved by the U.S. Food and Drug Administration (FDA) via a 510K process in 2006. It is also called Sorin 3T.
There is the potential for Nontuberculous mycobacteria (NTM) specifically Mycobacterium chimera bacteria to grow in a water tank in the heater-cooler units. Although the water in the heater-cooler unit does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or disperse the NTM through the device’s vent(s) or other small openings between the inside and outside of the water tanks into the operating room environment and the patient’s open surgical cavity. Water agitation (bubbling) inside the water tanks via pumps, mixing components, return circuit water, etc., may increase the potential for aerosolization of NTM bacteria.
As per Centers for Disease Control and Prevention (CDC) report, more than 250,000 heart bypass procedures are performed in the United States every year using heater-cooler devices routinely. Estimated 60 percent of these procedures performed utilize the devices that have been associated with these infections. Available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections. Research says infections caused by this bacteria are severe and can also cause a fatality.