Manufacturing company LivaNova PLC and its associates are facing major legal action, after numerous patients allegedly developed life threatening infections after using the company’s cardiac heater device.

The Stockert 3T Heater Cooler System, also called Sorin 3T Heater Cooler System, have been linked to rare non-tuberculosis infections after the device was used during heart surgeries.

In alleged result of these dangerous infections, LivaNova PLC is facing a heart surgery infection lawsuit.

The Stockert 3T Heater Cooler System consists of temperature controlled water tanks, which are meant to keep organs and blood at ideal temperatures during bypass procedures.

This device is very important to heart surgeries, as it preserves the heart during these high risk procedures.

Even though this cardiac temperature preservation device has helped numerous patients, there have been just as many complications reported.

According to the FDA, bacteria could be transmitted into the through the device’s exhaust vent into the environment and onto the patient.

The danger stems from the fact that bacteria could contaminate the water in the temperature control device, which could spread throughout the device and “aerosolize.”

Some of the complications associated with this product include the contraction of Mycobacterium chimera (M. chimera), which can result in death if not treated promptly.

Overview of Heart Surgery Infection Lawsuit

Due to these life-threatening complications, LivaNova PLC is facing a heart surgery infection lawsuit from an Iowa woman alleging major complications.

Plaintiff Debra P. is filing this heart surgery infection lawsuit on behalf of Ronald P., after he died from a heart surgery infection allegedly attributed the Stockert 3T Heater Cooler.

Debra claims that the company either knew or should have known the complications associated with their device.

The heart surgery infection lawsuit points out the University of Iowa Hospital and Clinics (UIHC) announced that 1500 patients who had undergone major heart, lung or liver surgery had been exposed to a rare and potentially fatal bacteria.

Between Jan. 01, 2012 and Jan. 22, 2016, patients who had undergone these procedures and had used the Stockert 3T Heater Cooler system for temperature regulation were at risk for potential infection.

Due to the fact that the particular bacteria is slow growing, it can take between two weeks to four years before patients show any symptoms.

Symptoms of M. chimera bacterial infection include:

• Fever
• Pain
• Night sweats
• Joint or muscle pain
• Weight loss
• Fatigue
• Unexplained fever

Treatment for this infection includes culturing and molecular diagnostic testing, but by latent stages it could be too late.

Both the FDA and CDC are warning patients and the medical community that the Stockert 3T heater cooler devices have been linked to M. chimera contamination in patients.

The FDA first warned against these complications in October 2015, when the agency stated it had received 32 Medical Device Reports of bacterial infections allegedly caused by the device.

In October 2016, the FDA stated health officials should be aware of the potential bacterial infections associated with the Stockert 3T Heater Cooler. Even though these warnings are helpful, they came too late for many patients.

Debra is filing this heart surgery infection lawsuit on behalf of her deceased loved one, seeking damages for negligence and wrongful death.

The LivaNova Heart Surgery Infection Lawsuit is Case No. 4:16-cv-00472, in the U.S. District Court of Southern Iowa.