A grieving widow is filing a wrongful death claim against Sorin Group USA Inc., alleging her husband developed an infection from open heart surgery.

The widow alleges that the infection occurred due to a contaminated cardiac heater cooler device that was used during her husband’s operation.  The cardiac heater-cooler device is supposed to help maximize the chances of the operation’s success.

Plaintiff Danna B. is filing this cardiac heater cooler lawsuit on behalf of her late husband Terrance B. Terrance underwent open heart surgery on April 17, 2015, after suffering a cardiac episode while exercising at his gym two days prior. This open heart surgery was extensive, repairing multiple parts of his heart. According to the cardiac heater-cooler lawsuit, the Sorin 3T cardiac heater cooler device was used in Terrance’s open heart surgery to help control his body temperature.

According to the lawsuit, the device caused Terrance to come into contact with a dangerous bacteria during the procedure. Terrance reportedly developed a latent NTM infection from open heart surgery, which ultimately resulted in his death.

Before his death, Terrance had multiple post-surgery follow up appointments.  The appointments occurred between May 2015 to September 2015 and it initially appeared as though Terrance was recovering well. However, beginning in January 2016, Terrance began experiencing fever and chills, with weakness in his legs occurring a month later.

Terrance was eventually diagnosed with the NTM infection after noticing an abnormal lump had developed in the scar area left from his open heart surgery. Even though Terrance underwent various treatment procedures, the NTM infection persisted and later caused his death.

Terrance died from multiple organ failure on Sept. 14, 2016, with medical records indicating the organ failure resulted from the NTM infection.

Even though this infection can be deadly, the widow alleges the company did nothing to warn her or her husband of potential dangers. Danna states she her husband never would have agreed to the device being used if he had known about the possibility of infection from open heart surgery.

Overview of Cardiac Heater Cooler Infection From Heart Surgery

The NTM (nontuberculosis mycobacterium) infection is a serious infection, which has been reported to develop in some patients after use of the Sorin 3T cardiac heater cooler device during surgery. NTM infection can be caused  by M. chimaera bacteria, and adverse event reports suggest that the dangerous bacterium has been causing infection from open heart surgery to develop.

Both the CDC and FDA have warned the medical community and general public the possibility of infection due to the Sorin 3T device. The Sorin 3T cardiac heater cooler device consists of two temperature controlled water tanks that do not make direct contact with the patient, but particles in the tanks sometimes travel through the exhaust vent.

This means that if the tanks are contaminated, the bacteria could make contact with the patient through the air vent, creating the possibility for serious infection after open heart surgery. According to the FDA and CDC, M. chimaera bacteria were discovered in the product manufacturing plants in Germany in September 2014 during testing.

While this problem was reportedly fixed in July 2015, the FDA is warning against using cardiac heater cooler devices manufactured before September 2014. At this time, at least 12 patients may have died, and there have been dozens of other cases of infection from open heart surgery.

This Cardiac Heater Cooler Lawsuit is Case No. 0:17-cv-04186, in the U.S. District Court for the District of Minnesota.