Several lawsuits filed against the makers of the Stockert 3-T Heater-Cooler System allege the device put patients at risk for infection. The claims further allege that the manufacturers were aware of the risks but failed to warn the medical community or consumers. According to claims, LiveNova and WellSpan Health knew the device allowed for the transmission of bacteria during surgical procedures, especially open-chest cardiothoracic surgeries. The first lawsuit filed in June 2016 claimed that the plaintiff had developed a mycobacterial infection during his open heart surgery procedure that utilized the Stockert 3-T system. Later that month, a similar complaint was filed by the family of a 62-year-old man who died after the system was used during his surgical procedure at York Hospital in Pennsylvania, which is owned by WellSpan Health. The following month, a South Carolina man filed a product liability lawsuit against LivaNova when he developed an NTM infection after his heart valve replacement and cardiac bypass grafting surgery. He claimed he was initially fine, but went on to develop weakness, a fever, and eventually pneumonia during his recovery from the procedure.

Contaminated Water in Heating-Cooling System Exposes Patients to Risk

Stocker 3-T heater cooler systems are used during surgical procedures to maintain a patient’s body temperature. The company also claims its device “improves medical care and patient outcomes.” The system uses tanks filled with temperature controlled water that is moved through a blanket that cools or warms a patient’s body during the procedure. Though the heating and cooling system was originally thought to be safe, research has revealed that the water in the systems can become contaminated and release bacteria into the air during operations through the device’s exhaust vent. If the bacteria come into contact with the patient there is a strong risk for Nontuberculous mycobacteria (NTM) infections. These infections can cause serious illness and be fatal. It’s also possible that a patient could be affected by exposure to the bacteria but not develop an infection for several years after an operation. This can make it challenging for doctors to diagnose the problem when a patient presents with symptoms because the link between the illness and the operation that occurred months or years ago is not immediately obvious. Furthermore, NTM infections are difficult to treat and have a high mortality rate. Nearly half of all people diagnosed with an NTM infection will die. There’s also a high-risk for needing surgery to remove a contaminated device or implant.

Stockert 3-T Devices Subject of FDA and CDC Warnings

Concerns about the Stocker 3-T device were serious enough that the US Food and Drug Administration (FDA) issued a recall of the systems in July 2015. The recall instructed hospitals and healthcare facilities to use a revised set of guidelines for maintaining their systems. Later that year, in October, the FDA issued a Safety Communication alerting the medical community and the public to the potential risk for infection when Stockert 3-T devices were used during surgical procedures. The communication noted that the agency had received 32 adverse event reports between 2010 and 2015. That same month, the US Centers for Disease Control and Prevention (CDC) issued a Safety Notice of its own identifying requesting that there be “increased vigilance for NTM infections” linked to the Stockert 3-T devices. Most recently, in January 2016, the FDA sent a warning letter to the original owners of Stocker 3-T concerning the safety violations that were revealed during an inspection of the manufacturer’s facilities which are located in Colorado and in Germany.