Patient Safety News: Heater-cooler systems used in heart bypass procedures linked to infections

The Sorin Stockert 3T heater-cooler system, a device used in heart, lung, and other chest organ surgeries, has been linked to dozens of infections in patients nationwide, including some who have died. At least three heart surgery patients in California were recently found to have been infected with bacteria that might have contaminated the devices during manufacture.

The patients had open chest cardiac surgery and survived their infections.

Infections caused by the slow-growing bacteria, Mycobacterium chimaera, are hard to diagnose. The bacterium is common in soil and water, where it rarely makes people sick. The heater-cooler devices have a water tank that is not supposed to come into contact with the patient. According to the U.S. Food and Drug Administration, if contaminated mist from the tank gets into the air, it can enter a patient’s open chest cavity or infect surgical implants.

About 60 percent of heart bypass procedures in the U.S. use the devices, which help control a patient’s blood and organ temperatures during surgery.

“The infections have occurred months or years following surgery,” said Benjamin Schwartz, acting director of the Los Angeles County acute communicable disease program.

Officials estimate the probability of infection is between 1 in 100 and 1 in 1,000. The FDA recommends patients who have had open heart surgery seek medical care if they experience night sweats, muscle aches, weight loss, fatigue, or unexplained fever.

The Sorin Group, maker of the devices, changed its name to LivaNova in 2015 after a merger. The FDA has found some infections tied to heater-coolers manufactured by other companies.

Officials have advised medical providers who continue to use the device to inform patients before their surgeries that the systems have been linked to infections.

Berman and Simmons, a leading firm that handles medical malpractice claims, represents many clients who have been injured by medical devices.

“People who have had heart bypass surgeries should contact their medical providers to find out if they used the Sorin Stockert 3T heater-cooler system and similar devices in those procedures,” said Susan Faunce, an attorney at Berman & Simmons who handles cases involving dangerous drugs and medical devices. “Patients who have been diagnosed with an infection after surgery should consider talking to an attorney.”