Stockert 3T is a heater-cooling machine used to regulate a patient’s body temperature in open-heart surgery or cardiopulmonary bypass surgery. Made by LivaNova PLC (formerly known as the Sorin Group Deutschland GmbH), Stockert 3T has been associated with the development of serious, life-threatening infections.
Those who have been seriously injured after exposure to a Stockert 3T system (or similar heater-cooler units) may be entitled to compensation for their injuries, suffering and losses.
The attorneys at the Amaro Law Firm are ready to review your potential Stockert 3T claim and advise you on your legal options. Dedicated, diligent and experienced, our lawyers can provide you with the advocacy and representation necessary to protect your rights, build you a strong claim and bring it to the best possible outcome.
Stockert 3T is a heating-cooling machine used in operating rooms. Surgical patients who’ve developed serious infections after exposure to Stockert 3T may have a claim against LivaNova.
Approved by the U.S. Food and Drug Administration (FDA) in June 2006,1 Stockert 3T systems have:
A water tank with separate chambers for warm and cold water
A heating and cooling unit through which air circulates.
Through closed circuits, the system provides temperature-controlled water to a warming-cooling blanket or an external heat exchanger. About 60 percent of bypass procedures performed in the U.S. involve the use of a Stockert 3T system.2
Other heater-cooling machines that operate similarly to the Stockert 3T include (and are not limited to):
While these systems are primarily used in heart surgeries, they can also be used in various lung and chest surgeries.
Stockert 3T Linked to Increased Risk of Serious Infection
Stockert 3T systems have reportedly caused some patients to develop serious M. chimaera infections, which can have deadly outcomes for those with compromised immune systems (like surgery patients).
Stockert 3T systems made in a specific German manufacturing facility were contaminated with M. chimaera bacteria. M. chimaera is a nontuberculous mycobacterium (NTM). Symptoms of these infections can take months to years to present themselves after initial exposure.
In some cases, however, this contamination reportedly occurred at hospitals when unsterile water was added to these systems.
Though patients do not have direct contact with the contaminated water, it can aerosolize in certain parts of these systems, transmitting bacteria via the air and the device’s exhaust vents. Once the contaminated air leaves the vent, it can be inhaled by patients and lead to potentially life-threatening infections.
An October 2016 report from the Washington Post found that as many as 500,000 surgery patients could have been exposed to contaminated Stockert 3T systems.6
FDA Warnings & Actions Regarding Stockert 3T Systems
Mounting patient reports regarding serious infections allegedly caused by Stockert 3T systems have spurred the FDA to take various actions against LivaNova, including (but not limited to):
Issuing LivaNova a Warning Letter – In December 2015, the FDA sent a warning letter to LivaNova regarding Stockert 3T systems, pointing out “significant issues, including quality system and premarket clearance violations.”3
Issuing a Public Safety Communication – In June 2016, the FDA’s Safety Communication specifically warned about the risk of chimaera infections due to contaminated water supplies in some Stocker 3T systems. Those at risk included patients who had undergone “cardiothoracic surgeries.”4 Officials at the Centers for Disease Control and Prevention (CDC) also issued a warning regarding the contamination and risk of infection associated Stockert 3T systems.2
The FDA continues to “actively monitor this situation and will provide updates as appropriate.” It also strongly urges anyone who has developed a serious infection after use of a Stockert 3T system in surgery to report the event to their Adverse Event Reporting program.5
Stockert 3T Lawsuits & Compensation
Many who have been developed serious infections due to contaminated Stockert 3T systems have filed lawsuits against LivaNova PLC, alleging that LivaNova:
Misrepresented the safety and efficacy of the Stockert 3T systems
Knew or should have known about the manufacturing flaws and the serious risks these systems posed to patients
Failed to warn the public about the risks associated with Stockert 3T systems.
While multidistrict litigation (MDL) has yet to be set up for Stockert 3T claims, those who have been injured by these systems continue to file lawsuits against LivaNova, seeking damages for (but not limited to):
Past and future medical bills
Pain and suffering
Loss of consortium
Funeral and burial costs (in the event of deadly outcomes).
Experienced Advocates Are Ready to Help You: Contact a Defective Medical Device Lawyer at the Amaro Law Firm
If you or a loved one has developed a serious infection after use of a Stockert 3T system, you can turn to an experienced defective medical device lawyer at the Amaro Law Firm for effective advocacy in the pursuit of justice and financial recovery.
Call (877) 892-2797, text (281) 612-8024 or email our firm for your FREE consultation and important answers regarding your potential claim.
Representing individuals and families from across the U.S. in Stockert 3T claims, we have a proven record of success in defective medical device (and other personal injury) claims, as affirmed by testimonials from our former clients, as well as our 5-star ratings on Google and Facebook.