The FDA (Food and Drug Administration) and CDC (Centers for Disease Control and Prevention) have warned that patients exposed to the Stockert 3T heater-cooler during surgery may be at risk for developing an infection that can cause serious illness or death. The Stockert 3T heater-cooler is a device used to regulate a patient’s body temperature during major heart, lung and liver surgeries where the patient’s chest is opened.
The Stockert 3T is manufactured by LivaNova (formerly the Sorin Group) in Germany. The FDA and CDC warn that the Stockert 3T may have been contaminated with bacteria found in the production line and water supply at the factory where it was built. This bacteria is classified as a “nontuberculosis mycobacterium” or NTM. Researchers say this bacteria can be released into the air in the operating room when the Stockert 3T is turned on. The bacteria can then come in contact with the patient, resulting in an infection.
What is the Infection Associated with the Stockert 3T?
The specific infection associated with the Stockert 3T is called mycobacterium chimaera (M. chimaera), and it can be deadly. While we often think of infections as developing rapidly and being easily recognized by doctors, M. chimaera is different. It develops very slowly and generally takes months – or even as long as five years – to begin to cause symptoms that doctors may recognize. This can lead to missed or delayed diagnosis, which allows the infection to continue developing, making it more difficult to treat when it is finally diagnosed. The FDA reports that the symptoms of this type of infection may include:
- Difficulty breathing
- Night sweats
- Persistent cough or cough with blood
- Joint pain
- Weight loss
How is a Patient Tested for M. Chimaera?
The testing for M. chimaera starts with an Acid Fast Bacillus (AFB) test. This test is often done with a blood sample, though it may also be done with sputum or other samples. The test results will tell your doctor whether you have an NTM (nontuberculosis mycobacterium) infection. If you test positive for NTM, more sophisticated tests – ultimately including DNA tests of the bacteria at issue – are then done to isolate the specific mycobacterium that is causing the infection. If you have an M. chimaera infection, that will be clear from the DNA testing.
Many hospitals are now sending letters warning patients who had open-chest surgery that they may be at risk of infection from the Stockert 3T heater-cooler and should be tested for the M. chimaera infection. Even if you have not received a letter from your hospital about the Stockert 3T, you should contact your doctor right away if you have had open-chest surgery in the last five years and suspect you may have an infection.
How Can the Use of the Stockert 3T Heater-Cooler Lead to an Infection?
You may wonder how a device that is intended to help a patient during surgery can result in the patient developing a serious infection. An understanding of how the Stockert 3T works will help to answer that question.
The Stockert 3T heater-cooler has two separate circuits of circulating water: (1) it pumps warm water that is used to keep the patient warm by controlling the patient’s blood temperature; and (2) it pumps cold water that is used to keep the “cardioplegia” (heart-stopping) solution cold so the patient’s heart can be temporarily stopped from beating while the open-chest surgery is being performed. As stated by the FDA:
“Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”
FDA Safety Communication, June1, 2016.
Am I Entitled to Compensation?
If you or someone you know has been exposed to a Stockert 3T heater-cooler during open-chest surgery, you may have a claim against the manufacturer of the Stockert 3T. Find out how Johnson//Becker PLLC can help you. Please contact us at 1-800-279-6386 or fill out the case review form here on our website and submit it for a free consultation.