Patients who underwent open heart surgery and developed infection are filing their own nontuberculous mycobacteria lawsuit, alleging the manufacturer failed to warn that their medical devices were contaminated.

Patients eligible to file their own nontuberculous mycobacteria lawsuit developed potentially fatal bacterial infections, allegedly as a result of the Sorin 3T Cardiac Heater Cooler devices being used in their open heart surgery. The patient filing their nontuberculous mycobacteria lawsuit are raising claims including negligence and failure to warn.

An example of pursuing legal action comes from a South Carolina couple, who filed a nontuberculous mycobacteria lawsuit stating LivaNova PLC’s cardiac heater cooler device had been directly responsible for a potentially fatal post surgical infection.

Plaintiff couple Ennis B. and Vickie B. filed the nontuberculous mycobacteria lawsuit, after Ennis developed a potentially fatal infection soon after her coronary artery bypass graft in March 2014.

Not long after her surgery, Ennis reportedly began experiencing chest pains and needed emergency treatment in April 2014. During which point, Ennis complained about chest pain and skin irritation on the incision site.

Even though Ennis was eventually diagnosed with nontuberculous mycobacteria infection, after being admitted to the hospital in May 2014. Ennis and Vickie opted to file their nontuberculous mycobacteria lawsuit, claiming LivaNova failed to warn them against potential infection and other counts of negligence.

Overview of Sorin Heater Cooler Bacterial Infections

The nontuberculous mycobacteria infection mentioned in the lawsuit stems from a rare bacteria found in water and dirt, but can be potentially fatal if it comes into contact with patients. Also called the mycobacteriaum chimaera (M. chimaera), this deadly bacteria was discovered in one of LivaNova PLC’s manufacturing plants in Germany in 2014.

The contamination was discovered during testing, but was reportedly resolved by July 2015 when the facility was tested again. The FDA states that the there is no risk of M. chimaera bacteria infections in Sorin 3T Heater Cooler devices manufactured after September 2014.

These potentially fatal bacterial infections have been officially linked to cases in Iowa, Michigan, and Pennsylvania from 2011 through the present. According to the CDC, there have been a total of 28 confirmed M. chimaera bacterial infections after patients underwent open heart surgery and used the Sorin 3T Heater Cooler.

Furthermore, the FDA stated at least 12 patients may have died in result of the bacterial infection. The FDA issued its first safety warning regarding the correlation in October 2015, when the agency reported it had received 32 Medical Device Reports (MDR) but did not specify which cardiac heater cooler device.

The FDA named the 3T Heater Cooler devices in a later warning in June 2016, stating these devices were linked with M. chimaera bacterial infections. The FDA’s most recent warning was announced on Oct. 13, 2016, with the agency providing healthcare facilities recommendations on how to prevent the infection from spreading.

Furthermore, the FDA warns patients and doctors that the onset of nontuberculous mycobacteria infections can take months or even years so patients should be vigilant for certain symptoms including:

• Night Sweats
• Aching Muscles
• Weight Loss
• Fatigue
• Sudden Fever