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Contaminated LivaNova Heater-Coolers Causing NTM Bacteria Infections in Open Heart Surgery Patients

Severe bacterial infections have been reported among numerous open-heart surgery patients whose surgeries included the use of a LivaNova/Stockert/Sorin 3T Heater-Cooler Device. Information from the Centers for Disease Control and Prevention (CDC) has shown that out of the 250,000 open-heart surgeries performed with the use of a LivaNova 3T Heater-Cooler Device studied, approximately 150,000 of those patients suffered a serious nontuberculous mycobacteria (NTM) or M. chimaera infection. The link between the use of this heater-cooler and a potentially fatal NTM infection is apparent.

At Shamberg, Johnson & Bergman, Chtd. in Kansas City, we have already heard and are helping several clients who have suffered a severe infection or the loss of a loved one due to an NTM infection related to open-heart surgery and the LivaNova heater-cooler system. We can tell you secondhand the dangers of this medical device and the infections it causes, and that you need to take legal action if you or a family member have been hurt in this way. The more clients we can assist with these NTM infection lawsuits, the stronger each case becomes as more and more related evidence and case results go on record.

Our attorneys are standing by to help you understand your rights and file a claim against all appropriate parties. No matter what hospital or medical group treated you, we can assist with your claim or lawsuit.

Issues with the LivaNova 3T Heater-Cooler System

The Food and Drug Administration (FDA) has issued several press releases regarding the proper use of the LivaNova 3T Heater-Cooler System, which might also bear the logos of Sorin and Stockert. The heater-cooler is used to add or reduce heat from an open-heart surgery patient through heat exchangers, warming/cooling blankets, and other methods.

According to the FDA findings, the 3T Heater-Cooler System can trap bacteria inside its water reservoirs. Due to design flaws in the device, the contaminated water can aerosolize and then contaminate the surrounding air with harmful bacteria, like M. chimaera or NTM. The operating theater for an open-heart surgery procedure must be absolutely sterile, so even a microscopic amount of airborne bacteria can pose an extreme infection risk to the patient and their large, open wound.

The FDA has recommended that medical professionals and facilities discontinue the use of the 3T Heater-Cooler System if other alternatives are available. If none are, then added precautions must be used to sterilize the heater-cooler and ensure that it cannot aerosolize the water within it while in use.

Damages in NTM Infection-Open Heart Surgery Lawsuits

You could be owed significant compensation if you or a loved one have suffered from the serious complications of an infection caused by a 3T Heater-Cooler System aerosolizing contaminated water while open-heart surgery was being conducted. You could be provided money to help pay for all medical treatments related to the heart surgery, infection treatment, and aftercare. Lost wages can be provided if you have missed work due to the infection, which is likely due to NTM often causing an infection with severe symptoms. Pain and suffering damages can be pursued as well to compensate you for the hardships you have endured.

In your NTM infection lawsuit, you might be able to demand compensation based on:

  • Negligence: The hospital and its staff where your open-heart surgery was performed can be liable for your infection and resulting injuries if it can be shown that it failed to appropriately maintain, clean, or position the heater-cooler unit for your surgery.
  • Product liability: LivaNova, the manufacturer of the 3T Heater-Cooler System, can be held liable for negligently designing an inherently flawed medical device. Strict liability rules can also hold LivaNova liable for your damages.

NTM Infection Symptoms & Complications

Symptoms of an NTM infection can take months or years to develop and are often general or nonspecific, such as fatigue, unexplained fever, night sweats, weight loss, or wound infection. As a result, the diagnosis of NTM infection can be missed or delayed. Healthcare providers may not immediately consider an NTM infection as the source of these symptoms. It is important that you communicate with your healthcare provider about your potential exposure to NTM bacteria. It is also important that if your provider is concerned about an NTM infection that they order the appropriate testing. We would encourage your healthcare provider to speak with an infectious diseases specialist to ensure the correct testing is performed.

Lawsuits Against University of Kansas Hospital Authority

Recently, our attorneys of Shamberg, Johnson & Bergman, Chtd., filed lawsuits against the University of Kansas Hospital Authority (KUHA) for patients and the families of patients who suffered a serious NTM infection after open-heart surgery was conducted at the medical facility and with the use of a LivaNova 3T Heater-Cooler System. One claimant became seriously ill with the infection, and the other claimant represents a patient who passed away due to the infection. Both cases happened in 2019, only a few months apart.

Please let us know if you underwent open-heart surgery at KUHA and suffered a serious infection afterward, or are concerned that you might have been infected with M. chimaera might not be a coincidence, and instead could be the direct result of medical negligence and an incorrectly designed piece of medical equipment. You might be owed significant compensation from KUHA, its doctors, and LivaNova.

We can assist clients from throughout Kansas and Missouri and who have suffered an NTM infection after surgery in any medical setting, not just the University of Kansas Hospital Authority. Call (816) 542-5999 or contact us online right away if you need our help. Initial consultations are completely FREE.

Continued Reading

  • CDC Health Alert: The CDC has warned hospitals and patients about the potential risk of NTM infections from certain heater-cooler devices used during open-heart (open-chest) surgeries.
  • Mycobacteria chimaera infection notes from the CDC: Notes from the Field: Mycobacteria chimaera Infections Associated with Heater-Cooler Unit Use During Cardiopulmonary Bypass Surgery — Los Angeles County, 2012–2016
  • FDA LivaNova heater-cooler warning: Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems: FDA Safety Communication
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