If you or someone you know has undergone open-heart surgery and suffered from a serious infection, this page contains information about the highly dangerous and potentially lethal infections, timeline of FDA events and warning letters associated with the Stöckert 3T Heater-Cooler System. As a consumer protection law firm representing individuals and families in all 50 U.S. states, we are available to answer any questions at no charge, and with no obligation.
Latest Known Facts:
- Three warning letters issued, and one recall
- It is believed there have been at least six deaths, with numbers expected to grow
- Originally developed by The Sorin Group, the product is often referred to as the “Sorin 3T,” or simply “3T”
- In 2015, Sorin merged with another medical device company to become LivaNova
- LivaNova is currently facing lawsuits due infections and deaths from the Stöckert 3T Heater-Cooler System
Multiple FDA Warnings Over the Heater-Cooler System
According to the Food and Drug Administration website, FDA.gov, the Sorin 3T received more than 32 adverse reports after use of it’s heater-cooler system. The reports were related to a highly lethal infection resulting in Nontuberculous Mycobacteria (NTM) infections.
In October 2015, this FDA issued this communication, stating: “We are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.” This notice was made for all heater-coolers; however, it is suspected that most events were attributed to the use of the Stockert/Sorin 3T system.
The October 2015 FDA letter also included nine steps and recommendations on proper use of heather-cooler devices with water tanks, as well as their cleaning and disinfection, in order to be safely used on American medical patients.
Eight months later, on June 1, 2016, the FDA issued another warning letter, this time specifically naming the Stockert/Sorin 3T system, and it’s potential association with Mycobacterium chimaera infections.
Are You Part of the “1 in 100 to 1 in 1000?”
According to the Center for Disease Control, Nontuberculous Mycobacteria infections are associated in 1 in 100 to 1 in 1000 infections. Of the 250,000 procedures done each year, approximately 60% of the open-heart bypass surgeries used the Stöckert 3T Heater-Cooler System. On the low end, this means that more than 150 individuals have been infected, potentially with Mycobacterium chimaera, which carries near 50% mortality rate.
The FDA’s most recent communication is from October 2016, which is an update from the June communication. However, the notice specifically referred to the “3T” device, and recommended the following:
Immediately remove from service any heater-cooler devices, accessories, tubing and connectors that have tested positive for M. chimaera, or have been associated with known M. chimaera patient infections at your facility.
Clearly, there is enough supporting evidence to show that the heater-cooler is defective, and may be at fault for infections and potential deaths, one of which has already been filed as a wrongful death lawsuit.
Have You or Someone You Know Been Affected?
If you or someone you know has undergone an open-heart bypass surgery, it is likely that during the procedure, the Stockert/Sorin 3T water heater-cooler system was used. If a post-operative infection developed and resulted in an extended hospital stay, or the wrongful death of a loved one occurred, please understand that these outcomes were likely avoidable.
Protecting yourself by understanding your legal rights costs you nothing, and carries no obligations or fees. You need to contact a law firm which has extensive experience litigating against medical device manufacturers, and their highly-compensated legal team. Put simply, you need an advocate. Our firm offers consultations at no charge, and with no obligation to pursue a case, should you choose not to.
While headquartered in Alabama, we have represented clients from Alaska and California, and throughout the country and eastern seaboard. Our location gives us a strategic position to be anywhere in the country in a matter of hours when our clients need help. If you or a loved one have been affected, it is likely you have a lot of questions, which can only be accurately answered by a lawyer who understands your case. You can reach us today to speak with a medical device lawyer by calling 866-515-8880.
Timeline of Stockert/Sorin Manufacturing Issues
- 2006 – As open-heart bypass surgery becomes an increasingly popular procedure in the 21st century, the Stöckert Heater-Cooler System is made available in the United States. It is estimated to be used is more than 60% of surgeries
- August 2, 2011 – FDA sends a warning letter regarding non-compliance over their S5 system. The letter from the FDA can be found here. A design change order was issued in December of 2011. It is believed that the design change led to the model designation “3T.”
- August 2014 – According to an FDA alert, testing conducted by the manufacturer found M. chimaera contamination on the production line, and water supply at the 3T manufacturing facility in Germany. Units from this facility can be found worldwide. In response to the M. chimaera findings in August 2014, the manufacturer added cleaning and disinfection procedures to the production line in September 2014.
- Dec 29, 2015 – The FDA issues a warning letter to the Sorin group regarding the inspection of their two manufacturing facilities in Germany and Colorado. it was determined that the devices were “adulterated” (read: modified). This letter can be found here.
- June 1, 2016 – An update to the 2015 safety communication from the FDA regarding patient safety when using heater cooler systems. The communication cited a European study specifically, and results, which traced back to machines manufactured in Germany. The results of this paper suggested a direct link between M. chimaera, to which the European cardiothoractic patients were exposed and became infected during open-chest cardiac surgery, and one specific heater-cooler model: the 3T.
- October 13, 2016 -The FDA issues a warning letter about the possible link between the use of the Stöckert 3T Heater-Cooler System in open heart surgeries, and mycobacterium chimaera infections.
Stockert / Sorin 3T Lawsuits & Settlements
Lawsuits are being filed against LivaNova PLC, the manufacturer of the 3T heating-cooling system, in conjunction with the transmission of bacteria into patients during surgery.
Nontuberculous mycobacteria infections (NTM), such as Mycobacterium chimaera, can cause serious illness, and in some instances, has been reported to carry a 50% mortality rate. While rare in occurrence, there is clear corporate wrongdoing by the manufacturer.
According to Mike Bradley, a Partner with our law firm, “It appears as though the manufacturer received multiple warnings regarding their systems and testing, which showed bacteria could thrive in the system. The manufacturer changed their product line to hopefully remedy the situation from occurring in it’s new products; however, LivaNova delayed to tell hospitals and doctors about the systems, which were currently being used in the United States. Bottom line: A lot of people got sick, and some died, and this was preventable, and why the company choose not to tell the public is what I intend to discover and share with my clients who have claims.”
You Need an Advocate
If you or someone in your family has been affected and believe it to be caused by the Stockert 3T system, having a legal advocate on your side can help make the process easier. Lawsuits with an international medical device company are complex by nature; however, our law firm has decades of experience fighting for our clients. We have recovered over $800 million on behalf of clients, ranging from doctors and other lawyers, to farmers, construction workers and business owners.
You likely have questions about your case, and we can help answer these for you. Our offices can be reached seven days a week by calling 866-515-8880. Consultations are absolutely free, and have no-obligation to pursue a case.
Testimonial: This firm represented my mother in a case against a medical company. She had to go through multiple awful surgeries, and I was there during the recoveries which were pretty unbearable at times. They were kind, listened closely, and talked to her about her case often. She was happy with her settlement and she is glad just to have her life back on track and to put this matter behind her. – Lucy H. California