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What is the LivaNova Heater Cooler device?

Heater-cooler devices are typically used during surgical and medical procedures that require the patient’s temperature to remain at a consistent level. The LivaNova heater-cooler – also known as the Sorin 3T Heater-Cooler – is a compressor-based system that uses three separate water tanks to provide adjustable temperature settings.

The LivaNova heater-cooler – also known as the Sorin 3T Heater-Cooler – is a compressor-based system that uses three separate water tanks to provide adjustable temperature settings. Although initially popular among medical professionals initially, concerns around contaminated water and the transmission of bacteria to patients using the LivaNova system have prompted a more cautious approach since late 2015.

How do surgeons use the device?

Heater-coolers are primarily used for cardiothoracic surgeries, serving to warm or cool the patient at key moments during the operation. The adjusted temperature can help to improve patient care and the overall outcome of surgeries.

Nearly 100,000 heart bypass procedures make use of the LivaNova heater-cooler every year in the U.S. This makes the device an important part of open heart surgery across the nation. By extension, the associated risks of the device are also important to consider.

What are the risks of the LivaNova Heater-Cooler?

Because heater-cooler devices use water to vary their temperature, the risk of contamination exists in the water tank. 

Patients do not have to come into direct contact with the device’s water to be infected. The LivaNova heater-cooler is not fully water retentive and does not use airtight seals. As a result, bacteria can be released into the air from the device’s exhaust vent. With the patient in close proximity and especially susceptible to bacterial infection, the contaminated water can indirectly work its way into their system.

Using a contaminated heater-cooler unit presents the risk of serious bacterial infection to the patient, the symptoms of which include:

  • Aching joints and muscle pain,
  • Weight loss,
  • Lethargy or fatigue,
  • Loss of sleep and excessive sweating at night,
  • Unexplained fever.

These health issues arise from the transmission of nontuberculous mycobacteria (NTM). Just as the symptoms of infection can vary, so can their severity. Many patients take months to experience these issues, yet the most distressing cases of contamination have caused severe injury and even death.

The Center for Disease Control and Prevention (CDC) assessed the infection risk of LivaNova heater-coolers as low as 1 in 100 patients, prompting a warning to healthcare providers and patients in 2016.

The dangers of Nontuberculous Mycobacteria (NTM)

Although it is not infectious to others, there are multiple dangers of NTM for individual patients who have been exposed to contaminated heater-coolers.

Because the bacteria is a slow-growing organism, initial symptoms might not be apparent for several months. In some cases, more than a year has elapsed before a patient’s subsequent illness was tracked back to a contaminated LivaNova heater-cooler unit. The longer the time that passes after surgery, the harder it can be to treat the resulting health problems.

As awareness of the heater-cooler problems increases, new cases – and warnings of potential infection – are coming to light. As 2016 came to a close, for example, several Indiana hospitals sent warnings to patients who had received heart surgery over the previous five years. In that case alone, thousands of patients will be alerted to potential infections, symptoms, and the dangers of NTM.

LivaNova Heater-Cooler Lawsuits

As contaminated heater-coolers are a relatively recent complaint – first alerted in late 2015 – legal action against LivaNova and Sorin is still in its initial phase. Individuals have filed lawsuits based on their own health complaints associated with heater-cooler assisted surgery, but there is currently no class action lawsuit against the device and its manufacturers.

One of the first heater-cooler lawsuits was filed in Pennsylvania when a man from York died after undergoing open heart surgery in 2014.  David Inners was 62 when he passed away and lived with the heater-cooler associated infection for almost one year after the procedure. 11 other patients came down with similar symptoms at the same time as Mr. Inners was suffering, leading medical investigators to focus their attention on York Hospital and the Milton S. Hershey Medical Center at Penn State. Subsequent lawsuits have focused on the manufacturer, first and foremost, but hospitals and other facilities using the device are not beyond the reach of litigation.

More complaints are registered and lawsuits filed every month. Once this movement reaches critical mass the potential for broader legal action will become clear.

If heater-cooler litigation follows similar medical device lawsuits, we can expect to see plaintiffs come together to consolidate their complaints against LivaNova and Sorin.

Damages awarded against LivaNova

Because the litigation is so recent, cases brought against LivaNova/Sorin and the medical facilities involved in using contaminated devices have not yet reached a tangible verdict or settlement.

However, with more than half a million patients in the U.S. undergoing open heart surgery in that time, heater-cooler litigation is growing. It is only a matter of time before financial damages are secured for patients who have suffered as a result of a contaminated device.

Whether this occurs in or out of court will come down to how aggressively LivaNova defends its equipment. With the groundswell of support for patients and government agency warnings already in place, it is recommended that potential plaintiffs evaluate their case with a legal expert.

Am I eligible to file a claim against LivaNova?

There is enough evidence about the dangers of LivaNova’s Heater-Cooler to suggest that plaintiffs can argue their related injuries were caused by the device.

Patients should speak to an attorney with expertise in this area to talk about their options for legal action. For help finding a lawyer who can help you with a LivaNova Heater-Cooler injury, call 1-800-DRUG-411 or request a case evaluation online.

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