The Sorin 3T Heater-Cooler System has been linked to M. Chimaera, a dangerous microorganism that can cause rare, deadly infections.
What is the Sorin 3T Heater-Cooler System?
The Sorin 3T Heater-Cooler System (also known as the Stockert 3T) is used to regulate a patient’s body temperature during cardioplegic surgeries. The Stӧckert 3T uses a closed-water circuit to regulate the temperature of bypass machines, oxygenators, heating or cooling blankets, and other equipment designed to keep the patient’s body at the ideal temperature for such procedures.
According to the Centers for Disease Control and Prevention (CDC), the substantial horizontal airflow generated by heater-cooler units might disrupt vertical ultraclean airflow, which could be a potential mechanism for transmission of pathogens from a contaminated heater-cooler unit to a surgical site.
M. Chimaera Infection – Rare but Deadly
In 2015, the U.S. Food and Drug Administration (FDA) and the CDC issued warning letters connecting the Stӧckert 3T to nontuberous mycobacterial (NTM) infections (M. Chimaera Infection). Then in October 2016, both agencies issued stronger warnings concerning the Stӧckert 3T. The CDC estimated the risk of contracting an infection to be between one in 100 and one in 1,000.
According to the CDC, there is a one percent risk that patients who have undergone cardioplegic surgery involving a Stockert 3T will contract M. chimaera. If the patient develops the infection, it will take months or years to exhibit symptoms, the first of which is an unexplained fever that lasts more than one week. Other symptoms of M. chimaera include:
- Low energy
- Night sweats
- Joint or muscle pain
- Redness, heat, or pus around the surgical incision
- Difficulty breathing
- Persistent cough
- A cough with blood
- Nausea and vomiting
Chimaera is fatal to approximately half the people who contract the infection. According to the FDA, of the 32 cases occurring between 2010 and 2015, nearly half the patients died. All of these patients had surgeries utilizing the Stӧckert 3T heater-cooler system.
Learn more about the Heater Cooler System Lawsuit here.
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If you received a note or believe you had an M. Chimaera infection related to the Sorin 3T Heater-Cooler System, feel free to check to see if you have a Heater-Cooler Case.