Cardiac heater-cooler devices effectively keep patients warm during heart surgery. However, they have been connected to NTM infections, a serious infection that can be destructive or even deadly.
What Are NTM Infections?
NTM is short for nontuberculous mycobacteria, naturally-occurring organisms that are found in soil and water.
There are over 150 species of NTM. Most of these species don’t cause illness in humans, and those that do tend to affect only those with a weakened immune system.
Sometimes a pulmonary NTM infection develops when a person inhales the bacteria, allowing it to reach the lungs. Most of the time, NTM organisms are cleared from the lungs naturally and don’t cause any type of serious NTM infections.
When NTM infections do set in, they can cause inflammation in the respiratory system. If left untreated, many patients will develop a progressive lung infection with symptoms such as a cough, shortness of breath, fatigue and weight loss.
These infections can become chronic and require ongoing treatment. The antibiotic regimen for an NTM infection can last for 12- 24 months.
NTM infections can affect patients at any age. When they become severe, NTM infections can have a serious impact on the quality of life of the patient.
NTM Contamination in the Stöckert 3T Heater-Cooler System
When a patient undergoes open-heart surgery, a medical device called a cardiac heater-cooler is often used. This device provides temperature-controlled water to other important surgical devices used in surgery.
These other devices are used to control the temperature of the organs or blood. When a patient’s temperature is under control during serious surgery such as this, their outcomes are improved.
But in the case of one particular make of cardiac heater-cooler, inspectors have found evidence of NTM contamination. The device in question is the Stöckert 3T heater-cooler system, a product of LivaNova PLC. Previous versions of this device were sold under the Sorin name by Sorin Group Deutschland.
Reports have begun to surface of patients who developed an NTM infection after undergoing open-heart surgery that used a Stöckert 3T system. Inspectors have also found evidence of NTM contamination at the manufacturing facility in Germany where these devices are made.
While the water in these devices does not come into contact with the patient, bacteria elsewhere in the machine can reach the device’s exhaust system. The bacteria can exit the device through its exhaust vent into the air of the operating room. This can potentially carry bacteria to the open surgical site and cause NTM infections.
The CDC reports that cardiac heater-cooler devices are widely used and are used in 60% of bypass surgeries in the United States, about 250,000 in all.
If you or someone you love contracted NTM infections following an open-heart surgery using a Stöckert 3T cardiac heater-cooler, you may be able to file a legal claim.
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