The Sorin lawyers at our dangerous products law firm are currently investigating personal injury lawsuit claims on behalf of individuals who suffered infection or the wrongful death of a loved one after a contaminated Sorin 3T heater-cooler device was used during heart surgery.
In recent years, a number of medical devices have been found to have the potential to become contaminated and spread dangerous infections to already ill hospital patients. Among these are the Bair Hugger forced air warming blanket, duodenoscopes made by multiple manufacturers, and most recently, the Sorin Stockert 3T heater-cooler device used during the majority of open heart surgeries in the United States. At least six patients in U.S. hospitals have died after contracting infections from a contaminated Sorin 3T, and regulators are not sure how many more contaminated devices may still be in use.
If you or your loved one contracted a serious bacterial infection after a Sorin 3T heater-cooler device was used during a cardiac surgical procedure, you could be entitled to compensation.
Overview: Sorin Stockert 3T Heater-Cooler Devices
The Sorin Stockert 3T is a medical device manufactured by a company out of the U.K. called LivaNova PLC. This device is used to regulate the temperature of patients undergoing open heart surgery such as coronary artery bypass procedures, replacement of heart valves, or the replacement of diseased aortic tissue. The Sorin 3T uses water to heat or cool blood which is circulated through a heart-lung machine. According to Reuters, the Sorin Stockert 3T accounts for roughly 60% of the market share for this type of device and is used in more than 250,000 open heart surgeries every year in the United States.
Sorin 3T may Cause Fatal Infections
Though the water that circulates through the Sorin 3T to heat or cool a patient’s blood never comes into contact with the blood, it has now been learned that bacteria may be present in this water and that the bacteria may become airborne when it is moved through the heater-cooler’s exhaust vent.
In the spring of 2015, clusters of patients in Switzerland and Germany became infected with an unusual bacteria. Since then, additional infections were reported in Europe and at least 28 such cases have been reported in the United States by hospitals in Pennsylvania, Iowa, and Michigan. The New York Times reports that at least six of the American patients who contracted this infection have died.
To identify the source of these deadly infections, the U.S. Centers for Disease Control and Prevention (CDC) studied samples taken from 11 infected patients and five Sorin 3T devices from two states. In each of these samples, they identified the same bacteria, M. chimaera, which they now believe originated at the German manufacturing plant for the Sorin 3T. Though representatives of the German plant say they first identified the bacteria in 2014 and have since disinfected the plant, clusters of infections have appeared across the globe since then and it is unknown how many machines may be contaminated.
About M. Chimaera Infections from Sorin Devices
Since the first bacterial infections were linked to contaminated heater-cooler devices in 2015, the FDA has issued multiple Sorin Safety Communications to warn hospitals, doctors, and patients about infection risks. They also issued a recall for the Sorin 3T system in July 2015.
In their most recent Sorin 3T Device Safety Communication issued on October 13, 2016, , the FDA states that infections caused by the bacteria M. chimaera found in these heater-cooler devices “are difficult to detect because infected patients may not develop symptoms or signs of infection for months to years after initial exposure.” This, it is imperative that patients who have undergone open heart surgery remain alert to possible symptoms of a nontuberculous mycobacterial (NTM) infection, such as:
- Redness, heat, or pus at the surgical site
- Muscle pain
- Joint pain
- Night sweats
- Weight loss
- Abdominal pain
Even patients who do not experience symptoms of a Sorin 3T infection should notify their doctors that they may have been exposed to M. chimaera bacteria during a surgical procedure so that they may be closely monitored for potential health threats.
Contact our Sorin Lawyers to Learn about your Rights
Although the plant where the Sorin 3T system was manufactured in Germany stated that they identified bacterial contamination and treated it in 2014, the FDA continues to receive reports of patient infections linked to contaminated heater-cooler devices used in heart surgery. In fact, the FDA has already received 25 reports of bacterial contamination in heater-cooler devices in 2016.
In Sorin lawsuits, plaintiffs allege that the medical device manufacturer neglected their duty to ensure patient safety by providing a safe product and promptly warning of known infection risks. If you or someone you love has suffered from an infection caused by a Sorin 3T heater-cooler, you may be owed compensation for medical expenses, pain and suffering, and other damages. Contact our Sorin lawyers today to learn more in a free legal consultation.