THL – TorHoerman Law

Stockert 3T Heater-Cooler SystemDevice Can Lead to Bacterial Infection

Heater-Cooler Device Lawsuit – Stockert 3T Lawyers

If you recently had open-heart surgery, you may have contracted an infection from the medical device that keeps your body warm during a surgical procedure.

The Stockert 3T Heater-Cooler System is a medical device that keeps your body temperature regulated during cardiac surgeries. The water tanks in the device can become contaminated with Mycobacterium chimaera either at the manufacturing plant where the device is developed or the hospital where the surgery occurs. The bacterium can cause Non-Tuberculous Mycobacterium (NTM) in patients with an open wound or poor immune systems. Numerous heater-cooler device lawsuits are currently being filed on behalf of those who contracted the potentially deadly infection.

Litigation Updates

Safety Warnings Updated by FDA

October 2016 - The FDA updated its safety warnings to include the risk of developing a bacterial infection, known as Mycobacterium chimaera (M. chimaera).

Steps to prevent a bacterial chimaera infection, for both surgeons and patients, from occurring were also included in the warning.

Read More Read Less

Safety Communication Warning Released

June 2016 - The FDA released the first safety communication warning associated with the Stockert 3T Heater-Cooler System. The warning directly notified both patients and surgeons of infections linked to the devices.

FDA Issued Warning to Manufacturer

December 29, 2015 - The FDA issued a warning to LivaNova PLC after inspections conducted at two manufacturing plants revealed significant issues and an increased possibility of contaminated heater cooler devices. The manufacturer recalled the instructions for use but did not recall the device itself.

FDA Became Aware of Alert Issued by Manufacturer

August 2014 - The FDA became aware of an alert issued by LivaNova PLC, the manufacturer of the device, about the device's potential to cause patient infection after a surgical procedure and begins their own investigation.

Hospital Asked for Investigation into Link between Device and Infection

May 2014 - Greenville Memorial, a South Carolina hospital asked state and federal investigators to investigate the link between the medical device and patients who developed an infection.

See More

What is the Stockert 3T Heater-Cooler System?

The Stockert 3T Heater-Cooler System is a medical device that regulates your body temperature during cardiac surgeries. Essential for life-saving surgeries, the device keeps circulating blood and organs at a constant temperature by heating and cooling the body during open-heart surgery.

In simple terms, the heater-cooler units keep your body at a constant temperature by providing temperature-controlled water to heat exchangers through closed circuits thus warming your body. The water never comes in contact with your body, but the three water tanks are potentially creating mycobacterium chimaera, a potentially deadly, but slow growing, bacterium to those with open wounds and low immune systems. Vapors exiting the device’s exhaust vent are polluting the air with bacterium could then enter the open wound during surgery.

Unfortunately, the source of the contamination can occur in two places – at the manufacturing plant and/or the hospital. The two potential contamination issues increase the risk of infection in patients.

The bacterium, commonly found in soil or water, is typically not harmful, but is slow growing and can cause infections in those undergoing surgery or suffering from a suppressed immune system.

Becoming available to the market in 2006, the device has been used in over 250,000 heart bypass surgeries throughout the United States. 60% of those surgeries used the Stockert 3T Heater-Cooler System.

The FDA has said that similar devices may also have the same design flaw as the Stockert 3T Heater-Cooler system that causes bacterium infections. The flaw relates to contamination during the manufacturing period.

Since 2010, about 79 cases of infection, including 12 deaths, caused by the use of the Stockert 3T Heater-Cooler System have been reported to the U.S. Food & Drug Administration. As a result, heater-cooler device lawsuit(s) are being filed across the country.

 

Injuries We’re Pursuing in a Stockert 3T Heater-Cooler Device Lawsuit

  • Non-Tuberculous Mycobacterium (NTM) – NTM infections caused by the mycobacterium chimaera bacterium can be deadly to those recovering from surgery situations where the immune system is not as strong. The bacterium enters the air through the contaminated medical device and enters the open wound. Detection of the infection often doesn’t occur until months or even years after the surgery, and as a result, can be difficult to discover.

 

If you believe you may be suffering from adverse side effects due to a Stockert 3T Heater-Cooler System used during your open-heart surgery, please contact a medical professional right away.

 

Contact a Stockert 3T Heater-Cooler Device Lawsuit Attorney

If you believe you contracted an NTM infection during an open-heart surgery, please contact a knowledgeable attorney.

At TorHoerman Law firm, we have a dedicated team of Stockert 3T Heater-Cooler Device lawyers who will be here to help you every step of the way. Our firm is a nationwide products liability firm that wants to help those suffering from a personal injury due to dangerous medical devices.

Our firm works on a contingency basis meaning you do not pay us until the case has been won. If we lose, no money will come out of your pocket. This ensures we work as hard as we possibly can for each of our clients.

If you have any questions or would like to schedule a free, confidential consultation, please either fill out the consultation form to the left, call us at 618-656-4400, or email info@thlawyer.com.

 

+ - References

"Contaminated Heater-Cooler Devices." Healthcare-Associated Infections, Centers for Disease Control and Prevention, www.cdc.gov/hai/outbreaks/heater-cooler.html.

"FDA's Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices." U.S. Food and Drug Administration, U.S. Department of Health and Human Services, 28 Mar. 2017, www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492590.htm.

Terhune, Chad, and Christina Jewett. "Deadly Infections Linked to Heart Surgery Device Highlight Holes in FDA Oversight." Kaiser Health News, Henry J. Kaiser Family Foundation, 30 Nov. 2016, www.scpr.org/news/2016/11/30/66678/deadly-infections-linked-to-heart-surgery-device-h/.

 

No-Obligation Free Consultation

Contact us by phone at (618) 656-4400 or email us below.

Sidebar Contact

Your information will be used only so that we may contact you to evaluate your case. Your contact information will never be shared or sold to anyone other than TorHoerman Law.