If you have undergone open heart or transplant surgery, chances are you were exposed to a heater-cooler unit, a medical device used to regulate a patient’s body temperature. A prominent model used in many hospitals in the U.S. is the Sorin Stöckert 3T Heater-Cooler System. Recently, lawsuits have been filed against Sorin, whose heater-cooler device many believe has increased the risk for potentially deadly bacterial infections.
The Stöckert 3T Heater-Cooler System
Heater-cooler units (HCUs) are designed to regulate a patient’s body temperature during cardiothoracic surgery. HCUs use a water tank to control temperature. Patients aren’t exposed to the water during surgery, but if the water becomes contaminated, bacteria could be spread from the device’s exhaust into the air, infecting the patient.
One such device, the Stöckert 3T Heater-Cooler System, hit the market in 2006 and is manufactured by Germany-based Sorin Group. Stöckert 3T sales account for approximately 60 percent of the U.S. market for HCUs. Studies in 2016 revealed that these units tested positive for M. chimaera, a type of nontuberculous mycobacteria (NTM). In response to these findings, the Food and Drug Administration (FDA) released an alert, warning doctors of the risk of infection associated with the Stöckert 3T.
Stöckert 3T Infection Risks
Lawsuits were filed against Sorin Group and parent company LivaNova PLC after patients developed M. chimaera and M. abscessus infections after undergoing surgery with the Stöckert 3T Heater-Cooler System. Over a quarter million heart surgeries using HCUs are performed each year, potentially putting thousands at risk.
The U.S. Centers for Disease Control and Prevention (CDC) estimates that one out of every 100 cardiac surgery patients could be at risk for a potentially serious NTM infection. These infections can result in life-threatening complications. Undergoing open heart surgery greatly increases the chance of infection because the patient’s defense against the bacteria is compromised.
NTM infection symptoms take time to develop and are difficult to identify, unfortunately. Some symptoms to watch out for include:
- muscle pain
- night sweats
- swollen lymph nodes
- coughing up blood
- lung infection
- heart lining infection
- septic shock
The FDA has identified three potential causes for why nontuberculous mycobacteria are being spread through HCUs.
- The water tank filters could be insufficient in keeping bacteria out
- Water in the HCU could be contaminated by air around it
- Exhaust from the HCU could be contaminating the sterile air in the operating room
Current Stöckert 3T Heater-Cooler Lawsuits
Class action lawsuits were filed in Pennsylvania, Iowa, and South Carolina on behalf of patients who underwent cardiac surgery prior to FDA and CDC warnings about the Stöckert 3T Heater-Cooler System. The cases were filed against Sorin and LivaNova, alleging that the Stöckert 3T HCUs had put patients at risk for potentially deadly infections.
In February 2018, the U.S. Judicial Panel on Multidistrict Legislation consolidated Stöckert 3T lawsuits under MDL No. 2816, in the Middle District of Pennsylvania.
Contact Jones Brown Law
If you or a loved one have suffered complications from an NTM infection after cardiothoracic surgery, you may be eligible to file a Stöckert 3T Heater-Cooler System lawsuit. The Jones Brown Law team has experience helping countless victims of defective drugs and devices, and we are currently accepting clients who have suffered infections caused by the Stöckert 3T HCU. To help us get started on your case and get you the compensation you deserve, please fill out our Jones Brown Defective Medical Device Evaluation by clicking HERE.