The Stockert 3T heater-cooler System commonly used during open-chest cardiac procedures to control a patient’s body temperature may be capable of transmitting a specific type of bacteria to patients during surgery, possibly putting them at risk for nontuberculous mycobacteria (NTM) infections from Mycobacterium chimaera. If you or someone you love has developed an NTM infection after undergoing surgery where the Stockert 3T system was used, contact an experienced product liability lawyer today to discuss your possible compensation options.
As a result of nontuberculous mycobacteria infections diagnosed in connection with the Stockert 3T heater-cooler system, attorneys across the country are investigating claims on behalf of patients who believe the manufacturer of the medical device, LivaNova PLC (formerly Sorin Group USA), was negligent in exposing patients to dangerous bacterial infections with its defective heater-cooler systems. According to a safety communication issued by the U.S. Food and Drug Administration (FDA) in October 2016, “[…] there is the potential for contaminated water to enter other parts of the [heater-cooler] device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”
To date, a handful of patients have brought complaints against LivaNova and Sorin, alleging that the companies manufactured a defective device and failed to warn patients and the medical community about the risk of NTM infections from the Stockert 3T heater-cooler system. One such lawsuit was brought on behalf of a man named David Inners, who underwent open-heart surgery in December 2014, and the following year died from an NTM infection that doctors linked to the use of a heater-cooler device during his surgery.
Lawsuits filed over alleged side effects of the Stockert 3T heater-cooler System allege that the manufacturer:
The FDA has issued several warnings associated with the use of the 3T, and has recommended detailed safety procedures that hospitals and doctors should take to prevent injuries.
Heater-cooler units like the Stockert 3T system are machines used during cardiothoracic surgeries to regulate a patient’s body temperature, providing temperature-controlled water via a closed-water circuit to external heat exchangers or blankets, which then provides cooling or warmth to the patient’s body. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 250,000 surgical procedures using cardiopulmonary bypass are performed in the United States every year, with the Stockert 3T heater-cooler system representing approximately 60% of the U.S. market. The Stockert 3T system is manufactured by LivaNova and is designed to optimize medical care and improve patient outcomes following surgery. However, there have been serious concerns in recent years about the potential for the Stockert 3T system to cause invasive cardiovascular infections in patients exposed to invasive bacteria from the heater-cooler unit.
Filing a Stockert 3T heater-cooler lawsuit against LivaNova could help cover the cost of:
The main concern raised in connection with the Stockert 3T heater-cooler system is the potential for the device to transmit Mycobacterium chimaera to patients during surgery, which can cause life-threatening nontuberculous mycobacteria infections (NTM). According to reports, the water in the heater-cooler unit’s tanks may be contaminated with M. chimaera, and while the water in the circuits never comes in direct contact with patients, the bacterium can be released into the air through the device’s exhaust vent and into the operating room and sterile surgical site. Although Mycobacterium chimaera occurs naturally in the environment and rarely causes problems for healthy individuals, it poses a serious risk for individuals with weakened immune systems, such as those undergoing invasive surgeries, and may result in nontuberculous mycobacteria infections.
Patients who have undergone cardiac surgery with a heater-cooler system should be aware of the possible symptoms and complications of NTM infections, which can occur years after the initial surgery, including fever, night sweats, weight loss, joint pain, fever, surgical site infection, endocarditis, and renal insufficiency. Unfortunately, because there can be a long delay between the time a patient is exposed to the Mycobacterium chimaera and when the patient begins to exhibit symptoms of an NTM infection, the infection can be difficult to detect, which increases the likelihood of serious illness or death.
