According to the Texas Heart Institute, thousands of heart surgeries are performed each day within the U.S. Approximately 500,000 coronary bypass surgeries have been performed in a recent year, and 2,300 people have heart transplant surgeries each year.

The Sorin Stockert 3T heater-cooler is a common medical device used during invasive procedures such as bypass surgery, and other surgeries involving the heart, lungs, esophagus, and other chest organs. Allegedly, however, the common device has been reportedly contaminated with bacteria, putting patients at risk for infection after bypass surgery.

According to reports, the bacterial strain Mycobacterium chimaera can grow within the tank of the 3T heater-cooler. It can then allegedly transmit an infection after bypass surgery to a patient as the bacteria can be emitted with water vapor into the surgical room. This exposes a patient to the allegedly deadly and serious infection.

According to reports, the U.S. Food and Drug Administration received 91 adverse event reports regarding the 3T heater-cooler system between January 2010 and August 2016. Of these 91 adverse event reports, 12 of these were linked to patient death and 79 were associated with incidences of infection.

The purpose of the Sorin Stockert 3T heater-cooler system is to keep a patient’s body temperature warm while the patient undergoes cardioplegia, defined as being the intentional and temporary cessation of cardiac activity, specifically for patients undergoing cardiac surgery.

M. chimaera, a subspecies of NTM, or nontuberculous mycobacteria, can colonize within the water tank. And although it is allegedly not a threat to healthy individuals, it becomes a threat for patients who have compromised, weak, and susceptible immune systems.

According to a report titled “The Heater-Cooler unit–A Conceivable Source of Infection,” researchers based in Germany had discovered the bacterial strain growing inside the medical device as early as 2002. They had discovered, just as being alleged, that M. chimaera can colonize within the tank, become transmitted through vapor coming from the devices’ exhaust fans and into the surgical and sterile operating room, contaminating a patient through an infection after bypass surgery.

According to the Centers for Disease Control and Prevention (CDC), the agency had provided warning to healthcare providers and patients admitted into hospitals and specifically undergoing open heart surgery of the potential risk for infection after bypass surgery.

According to the agency, they acknowledged that “more than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year.” They continued to maintain, moreover, “Approximately 60 percent of heart bypass procedures performed in the U.S. utilize the devices that have been associated with these infection.”

According to the CDC, in hospitals where one patient infection after bypass surgery has been found, the potential risk for other patients to contract the infection becomes 1 in 100 and 1 in 1000.

The CDC comments on remarks made by the deputy director of CDC’s Division of Healthcare Quality Promotion, Michael Bell, M.D. stating, “It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly.” He continues to say, “Hospitals should check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them.”