Stockert 3T Heater-Cooler
Manufactured by LivaNova PLC
This device is used during surgery to control a patients body temperature. Water tanks provide temperature controlled water to a heat exchanger or blanket that heats or cools the patients body. In the U.S., most cardiopulmonary bypass procedures involve the use of a heater-cooler device. There are about 250,000 heart bypass surgeries conducted each year, and 60% of those use the 3T device. Because of this, the CDC estimates that there are more than half a million patients at risk of infection.
Most of the water used in many systems is contaminated with Mycobacterium chimaera which is being released into the air by the machines exhaust vent. This bacteria is found naturally in the environment but presents risk to patients with weakened immune systems (especially those who have undergone invasive cardiac surgeries). M. chimaera infections are difficult to detect because infected patients may not develop symptoms or signs of infection for months to years after initial exposure. This exposure can result in nontuberculous mycobacteria infections (NTM). Some symptoms of infection in patients who have undergone cardiac surgery can include surgical site infection, abscess, hepatitis, renal insufficiency and endocarditis. Other common symptoms can include a fever of undetermined origin, night sweats, joint pain, muscle pain, fatigue and weight loss.
Testing for Mycobacterium chimaera is not standard protocol and due to the long incubation period can often present itself a significant time after the surgery occurs. There can be up to a 7 year delay between the time a patient is exposed to the bacteria and the infection occurring. CDC and FDA alerts both suggest looking back 4 years for infections in patients who underwent open chest heart surgery. If patients think they have been exposed, they should let their GP know so they can be aware of any changing symptoms. Even with appropriate combination antibiotic therapy, deaths have been reported. Mycobacterium chimaera carries a near 50 percent mortality rate.
Laird, Baker and Blackstock is currently evaluating cases for potential claims against the manufacturer of the Stockert 3T machine. If you have had open chest cavity surgery, have been diagnosed with this infection, or feel that you may be at risk, call our office or click the link below to schedule a free consultation. There is not a fee unless we recover.