LivaNova is a medical device company that manufactures the LivaNova 3T Heater-Cooler System — a controversial device that has recently been linked to harmful bacteria.
Heater-cooler systems are used during open-heart surgery and other medical procedures to warm or cool patients as necessary. The heater-cooler devices feature water tanks that transport temperature-controlled water to external heat exchangers or warming-cooling blankets through closed circuits.
According to multiple reports, it’s possible for the water used in several systems, including the LivaNova 3T system, to become contaminated, which can result in bacteria, including nontuberculous mycobacterium (NTM), to be released into the air through the system’s exhaust vent. As a result, patients may be been exposed to the harmful bacteria.
Why are Sorin LivaNova 3T Heater-Cooler Devices Dangerous?
LivaNova is currently conducting extensive testing and data collection in an effort to understand how nontuberculous mycobacterium (NTM) transmission may be occurring during the use of heater-cooler devices.
According to the medical device manufacturer, the failure to clean and disinfect a water circuit of a heater/cooler can allow biofilm formation. Nontuberculous mycobacterium is known to proliferate in biofilm and may lead to contamination of the heater-cooler water circuit.
In operation of the heater-cooler device, air bubbles may be generated in the water tanks and then exit the device as aerosolized particles. The NTM present in the water may be carried by aerosolized particles out of the tank. Via air flow, the aerosolized particles may then be dispersed into the surrounding environment.
The FDA released its first warning about heater-cooler devices and NTM infections in October 2015.
Two months later, the federal agency sent a warning letter in December 2015 to the Sorin Group, which became LivaNova. According to the FDA, Sorin Group failed to provide adequate information regarding how its new cleaning procedures prevent biofilm from growing in the heater-coolers.
CDC Issues Recommendations About Dangers of Sorin LivaNova 3T Heater-Coolers
The Centers For Disease Control and Prevention recently issued recommendations to health officials, healthcare providers and facilities to keep an eye out for nontuberculous mycobacteriumcan infections among patients who have undergone cardiac surgery, and to take all necessary precautions in order to prevent such illnesses.
Can I File A Sorin LivaNova 3T Heater-Cooler System Lawsuit?
Our Sorin LivaNova 3T Heater-Cooler lawyers can help if you or someone you care about contracted a severe — or possibly fatal — infection as a result of being exposed to bacteria from a contaminated heater-cooler device.
Our top Sorin LivaNova 3T Heater-Cooler System case lawyers are handling individual litigation nationwide and currently accepting new heater-cooler cases in all 50 states.
Both patients and their families are seeking compensation for injuries. You may be entitled to a settlement if you were harmed by a heater-cooler system.
Our No-Fee Promise On Sorin LivaNova 3T Heater-Cooler Cases
You can afford to have our great team of LivaNova heater-cooler lawyers on your side. If you choose us, it literally costs you nothing to get started. We promise you in writing:
- No money to get started
- We pay all case costs and expenses
- No legal fees whatsoever unless you receive a heater-cooler settlement
- Phone calls are always free
How Do I Start A Sorin LivaNova 3T Heater-Cooler Claim?
Our Sorin LivaNova 3T Heater-Cooler case lawyers will help you file your lawsuit. To get started, you can:
- Submit the Free Case Review Box on this page, or
- Call (866) 280-3417 any time of day to tell us about your case.
We will listen to your story and answer your questions. If you have a claim, we will start immediately.
WARNING: There are strict time deadlines for filing heater-cooler lawsuit claims.