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A New Mexico woman has filed a new Stockert 3T heater-cooler lawsuit against manufacturer Sorin Group Deutschland GmbH and the Sorin Group USA, Inc. The case was filed in the U.S. District Court for the District of Minnesota on September 8, 2017.

The plaintiff claims that her deceased husband, after undergoing surgery in which a 3T heater-cooler unit was used, suffered serious injuries.

Heart Surgery Leads to Serious Heater-Cooler Infection

According to the complaint, the decedent suffered a heart attack on April 15, 2015. He was taken to the Regions Hospital in St. Paul, Minnesota. Two days later, he underwent an open-heart surgery at the hospital.

During the procedure, a Stockert 3T heater-cooler unit was used to keep the decedent warm. The 3T heater-cooler is a medical device with water tanks that provide temperature-controlled water to warming/cooling blankets or other external heat exchangers during surgery. The water inside the device never comes into contact with the patient. However, contaminated water from inside the device can aerosolize and be pushed into the operating room through the device’s vent and exhaust fan. During surgery, the aerosolized bacteria can settle in the patient’s open surgical site.

The plaintiff claims that her husband developed a slow-growing, Mycobacterium chimaera (M. chimaera) infection from the heater-cooler unit that was used during his heart surgery. M. chimaera is a type of non-tuberculous bacteria that can cause a life-threatening, antibiotic-resistant infection.

Doctors Can’t Get Infection to Go Away

The decedent saw his doctor in July 2016, complaining of fatigue and sudden, rapid weight loss. He later noted an abnormal lump in the scar from his open-heart surgery. Doctors later removed a cloudy fluid from a sternal abscess near the scar and admitted him to the hospital.

In September 2016, the decedent started antibiotics to treat the infection. He also received blood transfusions and other treatment methods, but nothing worked. That same month, lab tests confirmed the presence of M. chimaera in the samples from his sternal tissue. The doctors then associated his infection with the heater-cooler unit used during the surgery.

Despite all their efforts, the doctors could not stop the decedent’s decline, and he died on September 14, 2016. The plaintiff states the heater-cooler infection ultimately led to her husband’s illness and death.

Manufacturer Aware of Infection Risks Prior to Alerting the Public

On October 13, 2016, the FDA released a safety communication warning that surgery with Stockert 3T heater-cooler devices had been linked with M. chimaera infections. The plaintiff claims that the manufacturer was aware of the issue long before that, and should have done more to protect the public.

In August 2014, for example, the company performed its own investigation of its manufacturing facility and found the presence of mycobacteria contamination on the heater-cooler units. The results of the investigation were not made public until nearly two years later. Instead, the company simply released a field safety notice indicating that “without vigilant” disinfection and maintenance of the units at hospitals and medical centers, bacteria could grow within the devices.

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