What is a Stockert 3T Heater-Cooler Device?

stockert-3T-heater-cooler-lawsuitsThe Stockert 3T Heater–Cooler is used to regulate a patient’s body temperature during surgery. This device is typically used during open-heart or chest surgeries.  The Stockert 3T works by heating or cooling water in separate tanks, and then feeds the temperature controlled water to blankets or heat exchangers which regulate a patient’s body temperature.  This system is closed-circuit so the water in the device itself does not come into direct contact with the patient.

However, the potential exists for the water inside this device to allow for the growth of a non-tuberculosis mycobacteria (also known as NTM) called M. Chimarea.   The bacteria-filled water from this device can turn into a gas and become airborne and pass through the device’s exhaust vent contaminating the otherwise sterile surgical environment.   The surgical site can become infected with NTM leading to a potentially fatal infection.

FDA and CDC Concerns Regarding the 3T Heater-Cooler

Both the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) have issued statements warning patients of mycobacteria infections associated with the Stockert 3T Heater-Cooler System.

  • “Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication”

    U.S. Food & Drug Administration (FDA) | October 15, 2015

    “The FDA wants to heighten awareness about infections associated with heater-cooler devices and steps health care providers and health facilities can take to mitigate risks to patients.”

  • “Mycobacterium Chimaera Infections Associated with Sorin Group Deutschland GmbH Stöckert 3T Heater-Cooler System: FDA Communications”

    U.S. Food & Drug Administration (FDA) | June 1, 2016

    “The FDA is providing new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T in patients who have undergone cardiothoracic surgeries.” Read More

  • “UPDATE: Mycobacterium Chimaera Infections Associated with LivaNoca PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T Heater-Cooler System: FDA Communications”

    U.S. Food & Drug Administration (FDA) | October 13, 2016

    “As the FDA continues to investigate infections associated with the 3T, we believe health care facilities should take additional steps to help mitigate the risk of infection associated with the use of these devices.” Read More

  • “Contaminated Devices Putting Open-Heart Surgery Patients at Risk”

    Center for Disease Control and Prevention (CDC) | October 13, 2016

    “The Centers for Disease Control and Prevention (CDC) is warning healthcare providers and patients about the potential risk of infection from certain devices used during open heart (open-chest) surgery.

    Patients who have had open heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever.” Read More

Hundreds-of-thousands of open chest surgery patients could be at risk of an infection.

Symptoms and Complications of an NTM - M. Chimaera Infection

The symptoms of non-tuberculosis mycobacteria (NTM) infection can take months to years to appear.   Patients who have undergone open chest surgery should be very careful to look for signs of infection that include:

      • Surgical site infection – heat, redness or pus around a surgical infection
      • Cough that won’t go away
      • Coughing up blood
      • Shortness of breath when active
      • Difficulty breathing
      • Fatigue
      • Persistent or Unexplained Fever
      • Night sweats
      • Weight loss
      • Joint pain
      • Muscle pain
      • Nausea or vomiting
      • Abscess

The following conditions can be symptoms and complications caused by a mycobacteria (NTM) infection:

      • Reduction in the number of red and white blood cells (also known as Pancytopenia)
      • Infection or inflammation of bone (also known as Osteomyelitis)
      • Infection of the lining of the heart (also known as Endocarditis)
      • Hepatitis
      • Renal insufficiency
      • Enlargement of the spleen
      • Bacteria in the blood
Stockert 3T Heater-Cooler Lawsuits

Stockert 3T Heater-Cooler LawsuitsLawsuits have been filed claiming that the manufacturer of the Stockert 3T Heater-Cooler, LeivaNova PLC (previously Sorin Group), manufactured a defective product and failed to warn doctors and hospitals of an increased risk of M. chimaera infection when the Stockert 3T was used during cardiothoracic surgeries.

M. chimaera is a kind of nontuberculous mycobacterium (NTM) that can cause serious illness or death. It is classified as a slow grower and can be very difficult to detect as infected patients may not experience any symptoms or signs of infection immediately following the initial exposure. These infections are difficult to detect and successfully treat.

It can take years for symptoms of M. chimaera to manifest and these infections can be deadly.

Our Stockert 3T Heater-Cooler attorneys are ready to help and are available to assist you from our many offices throughout New York State and Vermont, including locations in: Schenectady, NY, Saratoga, NY, New York City, NY, Plattsburgh, NY, Albany, NY, Buffalo, NY, White Plains, NY, Rochester, NY, – as well as Manchester, VT and Burlington, VT. Our call centers are available day and night to help protect your rights.

If you or someone you know has undergone an open chest surgery in which the Stockert 3T Heater–Cooler was used,  call us today at 1800LAW1010 (1.800.529.1010) to find out what legal action you may take regarding this defective product.