A Sorin 3T heater cooler lawsuit alleges that an Ohio resident died as a result of an infection that he contracted because of the use of a defective Sorin 3T Heater-Cooler System used during his heart bypass procedure. Allegedly, a problem with the device’s design allowed bacteria to enter the decedent’s body during his operation.

Plaintiff Dona F. has filed the heater cooler defect class action lawsuit against LivaNova Deutschland GMBH and Sorin Group USA Inc., on behalf of the estate of Harold K., claiming that defects in the company’s product, the Sorin 3T Heater-Cooler System caused Harold injury and resulted in his death.

Allegedly, Harold underwent open heart surgery at the Ohio State Wexner Medical Center to have a valve replacement. The Sorin 3T Heater-Cooler system was allegedly used during the open heart surgery, to help maintain the patient’s body temperature during the operation.

The Sorin 3T heater cooler lawsuit asserts that Harold did not recuperate from the surgical procedure, and was transferred to the Kindred Hospital Division of Mercy, St. Rita’s Hospital in Lima, Ohio because of his infection. Allegedly, an infection specialist there treated  Harold until his death on Dec. 7, 2016.

According to Dona, on behalf of Harold’s estate, Harold experienced fatigue, persistent fever, increased pain, and other related symptoms from the infection, symptoms that she claims were directly and proximately caused from the Sorin 3T Heater-Cooler used during  Harold’s open-heart surgery process.

Allegedly, the infection that Harold suffered was an infection of M. chimaera. The Sorin 3T Heater-Cooler System lawsuit argues that the design of the heater-cooler system allows for bacteria to be transmitted through the air into a patient’s body, despite the otherwise sterile operating environment.

According to Dona F. and Harold’s estate’s attorney, a 2016 study “published in the Journal of Emerging Infectious Diseases confirmed the airborne transmission of [M. Chimaera]” through the device because the exhaust fan in the device can “disrupt the ultra clean air ventilation systems of operating rooms.” Allegedly, the design cases contaminated water to pump though the device’s tubes and aerosolize.

Allegedly,  Harold contracted an infection in this manner, and died because of respiratory failure brought on by septic shock syndrome/infection from the M. chimaera.

The Sorin 3T Heater-Cooler lawsuit claims that the heater coolers can aerosolize bacteria like M.chimaera and carry them up to five meters from the device. Allegedly, the FDA hosted aa Circulatory System Devices Panel for the Medical Devices Advisory Committee to address the public health risk posed by heater-cooler devices like the 3T, and allegedly noted that almost 90 percent of the reports of infection were linked to the use of the Sorin 3T device.

The FDA reportedly continues to investigate the risk of infections and heater-cooler devices.  

Dona and Harold’s estate’s attorney says that after Harold’s death on Dec. 7, 2016, the Ohio State University Wexner Medical Center announced that many patients had been exposed to bacteria because of the Sorin 3T Heater-Cooler System. Allegedly, this warning was useless to Harold, who had died several days before the letter was mailed to him.

According to Dona and Harold’s attorney, research dating back as early as the 1980s indicates that M. Chimaera can be aerosolized through natural processes and is commonly found in water. Additionally, the medical and scientific community allegedly recognized that heater-cooler devices can have the potential to infect patients during operations as early as November 2002, and many M. Chimaera infections have been identified in cardiovascular procedures.

The infection problem also made headlines — Mass Device noted in October 2016 that the Centers for Disease Control and Prevention warned of the risk of infection with the Sorin device. 

Dona and  Harold’s attorney use this alleged information to assert that LivaNova Deutschland GMBH and Sorin Group USA Inc. knew or should have known that the design of the Sorin 3T Heater-Cooler system was defective and could cause infection.

The Sorin 3T Heater-Cooler Lawsuit is Case No. 2:19-cv-00834-EAS-EPD, in the U.S. District Court for the Southern District of Ohio, Eastern Division.