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Sorin 3T Heater-Cooler Lawsuits

The Sorin 3T Heater-Cooler System, used during various types of heart and lung surgeries, can spread a dangerous bacteria during the procedures causing serious infections, illnesses and even death. Lawsuits are currently being filed as a result of the infections caused by these products.

The number of lawsuits claiming LivaNova’s Sorin 3T heater-cooler systems caused injuries have more than doubled in the last year. Now, a federal panel has decided that the cases will be transferred to a single federal court in order to move them more quickly through the legal process. Our firm is currently representing individuals who have suffered infections as a result of the Stockert 3T Heater-Cooler System.

If you or a loved one has had surgery in which a heater-cooler device was used, you may be eligible for compensation. Depending on the severity of your infection/case, you could be compensated for:

  • Lost wages during hospital stays and treatment appointments
  • Medical bills resulting from complications
  • Pain and suffering caused by the infection, medical treatments, and recovery timeline
  • Economic damages from your injury
  • Emotional distress and loss of enjoyment of life

Click here to view the sample patient notification letter, sent from hospitals to their potentially infected patients.

CDC Press Release_ Sorin 3T Heater-Cooler

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What is the Sorin 3T Heater-Cooler Unit?

A heater-cooler unit is a machine used in most open-heart and open-chest bypass surgeries to regulate the patient’s body temperature during surgery, preventing them from becoming too warm or too cold. These devices are important for use in heart and lung (cardiothoracic) surgeries because they generally involve the intentional and temporary stopping of the patient’s heart and/or lung functions.

The most widely used model of heater-cooler system is the Stockert 3T made by LivaNova (the company formed by the merging of Sorin and Cyberonics, Inc. in June 2015), which was recently linked to the spread of a bacteria called nontuberculous mycobacteria (NTM). NTM has been known to cause serious illnesses, including chronic lung infections in “immune compromised” patients and can even result in death when left untreated. The Stockert 3T heater-cooler unit is used in approximately 60% of the 250,000 surgeries performed in the U.S. each year requiring the use of a heater-cooler unit.

The most common procedures in which a heater-cooler unit is used include:

  • Aortic anomaly surgery
  • Coronary artery bypass graft (CABG)
  • Cardiopulmonary bypass surgeries (most open heart/open chest surgeries)
  • Extracorporeal membrane oxygenation (ECMO)
  • Heart transplant
  • Heart valve replacement
  • Left ventricular assist device (LVAD) implant
  • Lung resection
  • Lung transplant
  • Pulmonary artery banding

How Does a Heater-Cooler Unit Work?

A heater-cooler device includes a water tank with a compartment inside that separates warm and cold water, as well as a heating and cooling unit that allows for air to flow in and air to flow out. The devices provide temperature-controlled water to an external heat exchanger (like a heart-lung machine) or to warming/cooling blankets through closed water circuits that are sealed off to prevent contact with open air.

Sorin Stockert 3T heater-cooler unit

 

Although the water in the closed circuits never comes into direct contact with the patient, there is always the potential for contaminated water to enter other parts of the device or transmit bacteria through the air via the device’s exhaust vent into the environment and the patient.

This mechanical process helps maintain an internal balance against external changes in a patient’s body temperature. The water used in the heater-cooler system is isolated from the cardioplegia solution used to intentionally and temporarily stop the patient’s heart as well as the natural blood circuits.

Broken down more specifically, heater-cooler devices play a few different roles in surgery:

  • They transmit the cardioplegia solution doctors use to stop the heart into the body.
  • They facilitate the blood flow within the patient’s blood circuit.
  • The water held in a heater-cooler device’s tanks is used in the external heat exchangers as well as warming and cooling blankets that help regulate a patient’s body temperature.

It’s in these water tanks that Mycobacterium chimaera can live. When these dangerous bacteria infect heart surgery patients, those patients and their families have the right to pursue a Stöckert 3T lawsuit.

Sorin 3T Heater-Cooler Symptoms & Side Effects

Use of the Sorin 3T Heater-Cooler system has been linked to serious infections, most notably Nontuberculous Mycobacteria (NTM) infection. If you or a loved one underwent any operation in which a heater-cooler unit was used (usually open heart or chest) and have experienced any of the following symptoms or complications, you may be entitled to compensation:

  • Fatigue
  • Difficulty breathing
  • Persistent cough or cough with blood
  • Fever
  • Pain
  • Redness, heat, and/or pus at the surgical site
  • Muscle or joint pain
  • Night sweats
  • Weight loss
  • Abdominal pain
  • Nausea
  • Vomiting
  • Infection (NTM)
  • Sepsis
  • Surgical Wound Infection
  • Endocarditis

Treatment for these complications can persist for months and even years, and if left untreated patients with NTM infections are at risk of death.

Sorin 3T Heater-Cooler Recall and FDA Warning

In 2010, the U.S. Food and Drug Administration (FDA) began to receive reports that patients were developing serious infections during cardiothoracic surgeries (on heart and/or lungs). By 2015, the FDA, through hospital surveys and research, determined that heater-cooler devices were responsible for the issues and by 2016, they were able to link the [growing number of] infections to the LivaNova Stockert 3T specifically.

In June 2015, Sorin, by then known as LivaNova, recalled the Stockert 3T Heater-Cooler devices due to these infections which were officially linked to the devices by the FDA. The recall stated that the infection potential is greater if device disinfection is neglected and maintenance is not performed per the instructions for use. It was discovered that the defective devices may have been in circulation up until 2014, with the first incident of infection reported as early as 2012.

In December 2015, the FDA issued a Warning Letter to LivaNova after inspecting two of its facilities, one in Germany and one in the U.S. The warning stated that during the FDA’s inspection of LivaNova’s German facility, investigators determined that the firm’s devices were “contaminated” in methods used for manufacturing, packaging, storing or installation and found that these practices were in violation of current Quality System regulations.

At the conclusion of the inspection, the FDA noted that as a part of the company’s recall, LivaNova issued an update to its cleaning and disinfection instructions following complaints of patient deaths due to infections caused by the Stockert 3T. But the FDA concluded that the acceptance criteria for the test did not demonstrate that the updated procedures produced a reduction in bacteria. The FDA stated that it will remain “actively engaged” in the process.

Sorin 3T Heater-Cooler Litigation

The number of lawsuits involving the Stockert 3T Heater-Cooler Unit have more than doubled in the last year. On February 1, 2018, 39 lawsuits over the heater-cooler devices were consolidated into a multidistrict litigation (MDL) in Pennsylvania. Additionally, at least 33 other state cases may be included in the MDL.

The lawsuits claim that the Sorin 3T spread bacteria during surgeries, causing serious infections or even patient deaths. The FDA has been investigating the devices and their relationships to infections since 2010. The devices were originally made by Italian manufacturer Sorin Group, but they merged with Cyberonics, Inc. in 2015 to form LivaNova.

If you or a loved one suffered complications after a surgery in which a heater-cooler system was used, you may be entitled to compensation. Contact the defective device lawyers at My Vaccine Lawyer immediately to learn more about your options. (800) 229-7704.

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