A woman from California recently filed a wrongful death lawsuit against LivaNova PLC and its subsidiaries, alleging the mycobacterium chimaera infection that killed her husband was caused by the company’s medical device, the Sorin 3T Heater Cooler.

Also known as the M. chimaera bacterial infection, stocks of the Sorin 3T Heater Coolers had reportedly become contaminated with the bacteria during its manufacturing process at a plant in Germany.

This contamination was allegedly not discovered until after the claimant’s husband underwent open heart surgery that had utilized the Sorin 3T Heater Cooler, which the plaintiff says allowed for the mycobacterium chimaera infection.

Plaintiff Dolores H. filed this wrongful death lawsuit on behalf of her husband Richard H., who underwent coronary artery bypass surgery on Jan. 3, 2015 and reportedly developed painful symptoms over a year after the procedure. This is typical in cases of mycobacterium chimaera infection, which can reportedly take months or even years to manifest after the procedure.

According to the wrongful death lawsuit, Richard had reportedly developed pimple like lesions on the surgical scars and was prescribed antibiotics in July 2016. However, his symptoms did not improve,  and she says the couple continued to contend with wound opening and draining.

Dolores says that Richard underwent a wound debridement and sternal wire removal procedure on Nov. 9. 2016, with culture samples confirming it was the M. chimaera infection on Nov. 29, 2016. Even with the extensive treatment, Richard eventually died from the M. chimaera infection on Jan. 1, 2018.

Dolores opted to file legal action after discovering the FDA warnings regarding the M. chimaera bacteria contamination.

Overview of M. Chimaera Infection in Sorin 3T Heater Coolers

Mycobacterium chimaera is a type of bacteria that is typically found in water and soil but can be potentially deadly if it enters the human body. The FDA and CDC reportedly discovered that Sorin 3T Heater Coolers were contaminated with the bacteria when a manufacturing facility was tested in Germany in September 2014.

The issue was reportedly resolved by July 2015 when the facility was retested, with the FDA stating that Sorin 3T Cardiac Heater Coolers manufactured after September 2014, shoulder not carry any risk of contamination.

The Sorin 3T Cardiac Heater Cooler consists of two temperature controlled water tanks that do not directly touch the patients. Bacteria inside the machine could escape through aerosolization. When this happens, the M. chimaera bacteria is released into the surgical environment and may enter through the surgical site.

These devices are used in hundreds of thousands of open heart surgery procedures to help control the temperature of blood and organs while under sedation, and are considered very important medical tools in the medical community. However, the FDA warned against M. chimaera infection in October 2015, noting that 32 Medical Device Reports (MDR) stated that cardiac heater cooler devices had allegedly caused deadly infections.

The FDA later identified the Sorin 3T Heater Cooler as the device in question in June 2016, and provided additional recommendations to health officials several months later. Patients who recently underwent surgery that utilized this cardiac heater cooler should be wary for the following symptoms:

• Night Sweats
• Muscle Aches
• Weight Loss
• Fatigue
• Sudden and Unexplained Fever

This Wrongful Death Lawsuit is Case No. 2:18-cv-8672, in the U.S. District Court of Central California.