The Stockert 3T heater-cooler system is a device commonly used during cardiothoracic surgeries such as heart and lung transplants to regulate body temperature. Since 2010, an alarming number of patients who had the device used on them during surgery have come forward showing symptoms of a dangerous infection that has a 50 percent mortality rate on average. The infection is caused by a type of bacterium called mycobacterium chimaera.
This bacterium enters the sterile surgical field and into a patient’s body by way of the Stockert 3T’s water tanks. The device uses three water tanks in a closed-water circuit to regulate the temperature of oxygenators, bypass machines, heating and cooling blankets, and other cooling and heating equipment. The device’s manufacturers assumed the device was sterile since it utilizes closed-water circuitry. Over 32 diagnosed cases of mycobacterium chimaera have proven this assumption wrong.
Individuals who have suffered from this infection are qualified to file a lawsuit against the manufacturer of the device. Multiple Stockert 3T heater-cooler lawsuits have been successful so far. Filing a lawsuit can help an individual recover from a painful, debilitating infection that shouldn’t have been contracted in a sterile environment to begin with. To take legal action, don’t hesitate to contact a Stockert 3T infection lawyer today.
The Facts About the Stockert 3T Heater-Cooler System
The Stockert 3T was originally manufactured by a company called Sorin and started seeing heavy use during the year 2010. It was sometimes referred to as the Sorin 3T. Today, a company called LivaNova owns the product. From the period of 2010 to now, more than 60% of all heart bypass surgeries used the Stockert 3T. That amounts to over 250,000 surgeries total. The device still sees heavy use today despite the fact that the FDA has issued several warnings about the risk of infection.
According to the CDC, the risk of developing mycobacterium chimaera after undergoing a surgical procedure where the Stockert 3T heater-cooler system is used is “between about 1 in 100 and 1 in 1,000.” As of December 2016, 32 cases of the infection have been reported to the FDA. Nearly half of those patients died. 8 of these cases happened in the United States while 24 occurred in Europe.
Mycobacterium Chimaera Symptoms and Complications
One of the reasons the mycobacterium chimaera infection is so dangerous is because the bacterium is slow-growing. Despite the fact that the water in the Stockert 3T unit never touches the patient on the operating table, the water in the device can transform into a gas and enter an immunocompromised patient’s lungs. There, the bacterium slowly takes hold and grows, causing an infection that’s incredibly difficult to get rid of.
Symptoms of the mycobacterium chimaera infection may not present themselves until months or even years after the patient has recovered from surgery. Typically, the first symptom a patient will notice is an unexplained fever. That fever is then commonly followed up with these symptoms:
- Redness, pus, or heat around the surgical incision
- Night sweats
- Joint or muscle pain
- In infant children, an inability to gain weight
- Difficulty breathing
- Nausea and/or persistent vomiting
- Persistent cough, often accompanied by blood
The infection caused by the Stockert 3T heater-cooler system is especially dangerous because it tends to be contracted by a patient who is already at a compromised level of health. After receiving major surgery like heart or lung surgery, the body is extremely immunocompromised and susceptible to disease and infection. By the time a serious infection like mycobacterium chimaera takes over and begins to exhibit symptoms, even multiple strong antibiotics are oftentimes not enough to stop it.
Patients with the infection sometimes have to undergo a second surgery to have an infected implant taken out. When the infection is contracted during heart transplant surgery, for example, the bacterium will inhabit the new heart, further endangering the patient’s life. A second surgery is not always enough to save the infected patient, however.
Get Your Life Back with a Stockert 3T Heater-Cooler Lawsuit
If you or a loved one has had open heart or lung surgery within the past few years and has experienced any complications related to a mycobacterium chimaera infection or has any of the symptoms listed above, don’t wait another day. Seek medical help as quickly as possible, and consider seeking legal aid when you are ready to do so. Thomas Law Offices, located in Louisville, Kentucky, is currently seeking clients who are eligible to file a claim against the manufacturers of the Stockert 3T heater-cooler system.
With our help, you can get the financial assistance you need to recover as well as send an important message to the medical device’s manufacturer. A 50% fatality rate is not acceptable. The FDA has placed multiple high level warnings on the device, but it is still seeing common use in operating rooms across the country. A Stockert 3T heater-cooler lawsuit can send a message stating that the device must be made safer or removed from our hospitals. Reach out to us to learn more.