3T heater-coolers can expose patients undergoing invasive surgeries to a potentially deadly bacteria, Mycobacterium chimaera.
Sorin Stockert 3T heater-coolers are used to regulate a patient’s body temperature during open-heart and other types of cardiothoracic surgeries. Some devices contain the bacteria Mycobacterium chimaera, which the heater-coolers can emit as a vapor in sterile surgical rooms. Exposure can be deadly for patients with vulnerable immune systems.
Though the manufacturer Sorin Group (now owned by LivaNova) recalled the device in 2015, the bacteria can take years to develop into an infection. Patients who underwent invasive surgery that used the 3T device are now filing lawsuits against LivaNova and their health care providers.
If you or a loved one underwent invasive surgery with a 3T heater-cooler and developed an infection, you may be entitled to compensation. Contact us today for a free legal review.
About the Sorin Stockert 3T Heater-Cooler
In 2006, Sorin Group, an Italian-based medical device company, introduced the Sorin Stockert 3T in the U.S. The 3T heater-cooler regulates patients’ body temperatures primarily during open-heart surgery, but also with surgeries involving the lungs, esophagus, and other chest organs.
The device uses three water tanks and circuits to simultaneously keep patients warm while also using cold water for cardioplegia—the intentional and temporary cessation of cardiac activity during surgery. Closed circuits are used to move the water and temperature to external devices, like heating and cooling blankets.
Since merging with Dallas-based Cyberonics in February 2015, the company continues to manufacture and sell the 3T heater-cooler under LivaNova, a London-based medical device manufacturer.
3T Spreads Bacteria Throughout Surgical Rooms
The heater-cooler fan can send bacteria 5 meters from the device, reaching a patient’s open heart cavity.
Open-heart surgeries are tricky procedures that come with a host of health risks. Instead of helping to stabilize patients during these surgeries though, the 3T heater-cooler can compromise their health even more.
As early as 2002, scientists in Germany discovered that the bacteria Mycobacterium chimaera (M. chimaera) could grow inside 3T water tanks, eventually emitting a vapor that the device’s exhaust fan spreads across sterile operating rooms. A June 2016 report in the Journal of Emerging Infectious Diseases reveals that the exhaust fan could send bacteria as far away as 5 meters from the device, reaching a patient’s open heart cavity.
M. chimaera is a bacteria subspecies of nontuberculous mycobacteria (NTM), or environmental mycobacteria. NTM is typically found in soil and water. Exposure to M. chimaera is usually safe for humans, but patients with vulnerable and compromised immune systems are at risk of developing deadly infections from exposure.
Infected Patients Have a 50% Chance of Survival
Even with treatment, there is a 50% mortality rate.
The chances of patients developing an NTM infection from the bacteria are typically somewhere between 1 in 100 and 1 in 1,000, according to the Centers for Disease Control and Prevention (CDC). The CDC warns though that patients who had valves or prosthetics implanted during surgery have a higher risk of infection.
Infections are difficult to treat and require concoctions of the highest-strength—patients receive an average of five different antibiotics. Patients may also have to undergo an additional surgery to remove infected valves or prosthetics. All of this combined, a 2009 study discovered that the average treatment for an NTM infection lasts more than two years and costs $19,876.
Even with treatment, there is a 50% mortality rate. Between 2010 and 2015, the FDA received 32 cases of NTM infections—nearly half of those patients have since succumbed to the infection.
The bacteria can have a long incubation period, but the majority of patients will develop symptoms within four years if they have an infection.
Common NTM infection symptoms include:
- Muscle aches
- Unexplained weight loss
- Draining from wound
- Night sweats
While a test can’t determine exposure to the bacteria, if patients do have these symptoms doctors can confirm an infection by using a Mycobacterium blood culture.
Bacteria Accumulates After One Day
90% of reports submitted to the FDA about contaminated medical devices were for the 3T heater-cooler.
Between inadequate cleaning instructions and design flaws, the 3T heater-cooler requires around-the-clock disinfecting to be safe for use. In their 2016 Circulatory System Devices Panel, the FDA revealed that from January 2010 and February 2016, 90% of reports about contaminated medical devices were for the 3T system.
In April 2011, the FDA recommended that the company modify its cleaning instructions since their recommendation to clean every 14 days didn’t prevent M. chimaera growth. The FDA discovered that after only a mere one and half days, the device could grow bacteria in quantities exceeding safe standards.
In July 2015, the company issued revised cleaning instructions. Ignoring the research that showed bacterial growth after one and a half days, the company recommended two different cleaning procedures for every seven and 14 days. If users hadn’t followed cleaning instructions for a long time, Sorin Group recommended mechanically deep disinfecting the device. However, a report submitted to the FDA in July of 2016 showed that this process did not remove the bacteria in significant amounts.
On June 15, 2015, the Sorin Group finally issued a recall of the 3T device, stating that there was “potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance is not performed per instructions for use.”
More than Half a Million Patients Could be at Risk
There are about 250,000 heart bypass surgeries conducted each year, and 60% of those use the 3T device. The CDC estimates that there are more than half a million patients at risk of potential exposure.
As of October 2016, there were at least 21 reported cases of infection in Pennsylvania alone, resulting in six deaths. York Hospital claims 12 of those cases; six of their patients have passed away from infections caused by the 3T heater-cooler.
More than 14 patients have filed lawsuits against York’s owner, WellSpan Health, and LivaNova for exposing them to the deadly infection. Lawsuits have also been filed against other health care providers, including Penn Presbyterian Medical Center.
Contact Us for a Free Case Review
If you or a loved one developed an infection from the 3T Heater-Cooler, you may be entitled to compensation. At ClassAction.com, our legal team has recovered more than $2 billion from large corporations for over 200,000 clients.
Contact us today for a free, no-obligation legal review. There are never any costs unless we win a jury award or settlement.