What is the Sorin 3T Heater-Cooler?
The Stӧckert 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), provides temperature-controlled water for use in open heart surgery where cardioplegia (paralysis of the heart) is necessary to complete the procedures. Temperature-controlled water flows through the device’s tubes and is used to improve outcomes and optimize patient care during and after surgery.
According to the CDC, more than 250,000 heart bypass procedures that use heater-cooler devices are performed in the United States every year. Infection reports as a result of the devices surfaced as far back as 2012 with patients complaining of symptoms such as fatigue, fever, pain, night sweats, weight loss, and redness, heat, or pus at the surgical site. There are reports of at least six deaths as a result of infection.
Finally, after over two dozen adverse reports of infections linked to the Sorin 3T heater-cooler devices were collected from January 2010 to August 2015, the Food and Drug Administration (FDA) issued a Safety Communication in October 2015. In it, the FDA linked severe infections to the devices. Infections have also been reported outside of the United States from surgeons in Switzerland and Germany who saw severe bacterial infection outbreaks in postoperative patients.
How does the Sorin 3T Heater-Cooler spread infection? According to the manufacturer, contaminated devices shipped from their plant in Germany containing the bacteria were the cause of the outbreak. Data such as tissue samples from infected patients and other information helped uncover the link between the heater-cooler machines and the health problems.
Infections from the Sorin 3T Heater-Cooler
There are two known infections caused by the Sorin 3T Heater-Cooler devices: Mycombacterium chiamera (often shortened to M. chiamera) and Mycombacterium abscessus (or M. abscessus). Both infections are known to be slow growers but can be injurious or fatal.
One of the most recent Sorin 3T Heater-Cooler lawsuits involving a patient infected after the device was used in his liver transplant alleges many severe symptoms such as fever, diarrhea, and abdominal pain. In addition to undergoing intensive antibiotic treatment, the patient endured multiple hospitalizations, blood transfusions, debridement surgeries (which removed necrotic or dead tissue from the infected area), malnutrition, and other health problems.
Patients who present with the following symptoms and who had surgery involving Sorin 3T Heater-Cooler devices even months or years ago should seek treatment:
- Fatigue or tiredness
- Pain at the surgery site or abdominal
- Redness, heat, or pus at the surgical site
- Muscle pain and joint pain
- Night sweats
- Weight loss
- Nausea and vomiting
If you were a patient who experienced surgery and that surgery used a Sorin 3T Heater-Cooler device, or you were sent a letter from the hospital that your surgery involved this device and you may need medical monitoring for years to avoid and mitigate the problems of infection, you may qualify for right to compensation. Contact The Brad Hendricks Law Firm in Little Rock, Arkansas, for a free consultation.