The family of a deceased woman has filed a Sorin lawsuit against LivaNova, alleging that the company’s cardiac heater cooler caused their deceased relative to develop a deadly infection.

Plaintiffs William C. and Melissa E. recently filed a Sorin lawsuit against manufacturing company LivaNova on behalf of their deceased relative Donna C. after she developed a deadly infection allegedly caused by the use of a LivaNova cardiac heater cooler during a previous surgery.

In May 2015, Donna allegedly underwent open heart surgery during which a Sorin heater cooler was used to maintain her body temperature. Beginning in 2017, Donna’s health started to deteriorate and she developed fatigue, fever, chills, weight loss, and night sweats. That March, cultures were collected which later showed that Donna had developed a M. Chimaera infection. After being treated for the graft infection, Donna died in July 2017.

The Sorin lawsuit claims that the use of a LivaNova cardiac heater cooler during Donna’s open heart surgery caused her to develop a deadly infection. The Sorin/Stockert 3T heater cooler systems were commonly used during the bypass surgical process to maintain blood temperature. The machines circulate water through tubes into a heat exchanger where it can then warm the blood. Water tanks on the machine aerosolize water which is emitted from process. Although this allows the machine to vent, the Sorin lawsuit argues that it can increase the chance of deadly infection by M. Chimaera.

“The 3T System, as manufactured by the Defendants, directly transmits bacteria, including M Chimaera, to patients during invasive surgery,” the Sorin lawsuit argues.

M. Chimaera is a relatively harmless bacteria that is found naturally in the environment. In its natural form it rarely causes illnesses. However, alleges the Sorin lawsuit, when aerosolized through the Sorin cooler heater, the bacteria can come into contact with exposed organs in the previously sterile surgical field. Patients exposed to M. Chimaera usually take anywhere from several weeks to six years to develop an infection, but once symptoms present themselves the infection can prove deadly.

In response to numerous studies showing that the Sorin/Stockert 3T heater coolers were associated with M. Chimaera infections, the U.S. Food and Drug Administration (FDA) contacted healthcare providers in June 2016 warning them about the potential risk. This notice warned healthcare providers of the risk so that it could be avoided in the future and the Sorin lawsuit contends that LivaNova should be held accountable for the injuries sustained due to their device.

“Defendants knew or should have known that NTM, or other harmful bacteria were likely to colonize within the 3T and could be spread to patients during surgery through the exhaust vent,” the Sorin lawsuit claims. “The foreseeable risks of using the 3T, particularly severe bacterial infection and/or death, significantly outweigh the benefits conferred upon patients using the 3T.”

The Sorin lawsuit accuses LivaNova manufacturing defect, breach of warranties, fraud, wrongful death, and violation of Indiana consumer protection laws. In their Sorin lawsuit, Donna’s relatives seek economic damages, statutory damages, punitive damages, court costs, and attorneys’ fees.

The Sorin Lawsuit is Case No. 1:18-cv-02313-TWP-DLP in the United States District Court for the Southern District of Indiana.