Sorin Heater Cooler Device
Sorin Heater Cooler Device
No surgery is without risk. In fact, doctors take care to inform patients of any potential risks and receive their written consent prior to performing a procedure. However, for some of the 250,000 open heart surgery patients in the United States, the warning of potential risk of infection has come too late. The Centers for Disease Control (CDC) has reported that the Sorin Stöckert 3T heater-cooler devices, which were used in approximately 60 percent of heart bypass procedures performed in the United States, were contaminated during manufacturing, putting patients at risk for life-threatening infections.
The Sorin Stöckert 3T Heater-Cooler System, manufactured by LivaNova PLC (formerly Sorin Group Deutchland GmbH), is a device used during open heart surgery to keep the patient’s circulating blood and organs at a specific temperature during the procedure. Heater-cooler devices have water tanks which provide temperature-controlled water to external heat exchangers and warming/cooling blankets through closed circuits. While the water in the circuits does not come into direct contact with the patient, contaminated water can enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.
In 2015, the CDC and U.S. Food and Drug Administration (FDA) published information about heater-cooler devices, which have been associated with nontuberculous mycobacterial (NTM) bacterial infections in patients. In June 2016, the FDA specifically noted that the Sorin Stöckert 3T Heater-Cooper system had been directly linked to NTM infections in patients who had undergone open-chest cardiac surgery. Further, in October 2016, the CDC published reports that recently completed laboratory tests showed that bacteria from the Sorin Stöckert 3T Heater-Cooler System — known as M. chimaera — matched the bacteria found in patients in several states. Those results built on previous evidence from Europe that suggested the bacteria contaminated these devices during manufacturing in Germany.
The CDC has warned healthcare providers and patients about the potential risk of infection from the Sorin Sorkin 3T Heater-Cooler Device. M. chimaera may cause serious illness or death. Because infected patients may not develop signs or symptoms of infection for months or years, they are difficult to detect. Patients who have undergone open heart surgery should seek medical care if they experience symptoms associated with infections, which includes muscle aches, night sweats, fatigue, weight loss, or unexplained fever.
The injury attorneys at Leonard Legal Group in New Jersey are recognized leaders in the field of personal injury law with experience in medical product liability. Our experienced team assists patients who have developed complications from the Sorin Stöckert 3T Heater-Cooler system. Attorney Scott G. Leonard is Board Certified by the New Jersey Supreme Court as a Civil Trial Lawyer. His proven track record of success and excellence in representation has earned him inclusion in the list of New Jersey Super Lawyers from 2008-2017. If you or a loved one has undergone cardiac surgery that involved use of the Sorin Stöckert 3T Heater-Cooler system, contact our office today at 973-984-1414 or online. We will fight tirelessly on your behalf to secure the financial compensation you deserve.
Phone: (973) 984-1414
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Morristown, NJ 07960
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Franklin Lakes, NJ 07417