Infection Risk from LivaNova Stockert 3T Heater-Cooler Devices on Heart Lung Bypass Units
Protecting the rights of those injured from defective medical devices throughout South Carolina
People who have had cardio-thoracic surgery since 2008 may have been exposed to a dangerous infections which has been linked to a heater-cooler device, and officials from the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) are warning patients about the risk of possible infection from nontuberculous mycobacteria (NMT) that can cause illness and death.
At the South Carolina law firm of McGowan, Hood & Felder, LLC, we are here to protect the rights of our clients who have been exposed to a potentially deadly infection from defective medical equipment used during surgery. We fight to win the compensation you deserve when a defective medical device has caused an injury.
What is a heater-cooler device?
Heater-cooler devices are machines that surgeons use during cardiothoracic surgical procedures (surgeries where the chest is opened up) to regulate the patients’ body temperature. During procedures like open-heart surgery where the heart is stopped for a time, these machines regulate the body’s blood flow and maintains an even temperature. The device has water tanks with temperature-controlled water which flows through heat exchangers or to warming or cooling blankets through a closed circuit. The FDA website has a schematic that illustrates how these heater-cooler devices work during surgery.
Which heater-cooler devices are the culprit in spreading bacterial infections?
The CDC reports that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, which were used during cardiac bypass surgeries, were likely contaminated during the manufacturing process in Germany.
At the end of 2015, the FDA sent a warning letter to the Sorin Group in Germany, with a list of violations that they found when they inspected the facility with regard to their manufacturing and quality management systems.
What is the problem with Stöckert 3T Heater-Coolers?
Heater-cooler devices work in conjunction with heating and cooling blankets, which are used to regulate a patient’s temperature during surgery. The concern regarding Stöckert 3T heater-coolers is that the water in the tanks can easily become contaminated with bacteria – specifically Mycobacterium chimaera – which is then released into the air through an exhaust vent. Because these heater-coolers are used during open heart surgery, the bacteria can infect the patient. Additionally, some patients have been exposed to a second bacteria – Mycobacterium abscessus – which is released through the exhaust system of the device and the aerosol can contaminate a sterile surgical field.
Even though certain patients may not yet have contracted the infection, they were exposed to the mycobacterium during a surgical procedure. The FDA has advised all hospitals with this medical device where open heart procedures were performed at their hospital to send out letters warning patients of the potential exposure to this terrible infection. These people have cases for medical monitoring and mental anguish.
The CDC reports that about 600,000 patients are at risk for infections, and they have confirmed infections in 28 heart surgery patients in the United States, and 12 patient deaths worldwide from heater-cooler infections. These figures may be under-reported due to lack of knowledge of the cause of the infections in these heart surgery patients.
The Veterans’ Administration is also warning patients about infection risk from heater-cooler devices
The Veterans Administration National Center for Patient Safety (VA) has issued a statement about heater-cooler hazard summary. It is notifying patients who had surgery using one of the devices in question that they might have been exposed to the infection during surgery, and it is offering patients the option to come back in and get tested for no charge. Because the infection can take as many as five years to produce symptoms, people may have to get tested over time to rule out the infection, which can cause damage to heart valves and other organs.
Contact a South Carolina law firm that has extensive medical device malfunction experience
At McGowan, Hood & Felder, LLC, you and your family are important to us. Our South Carolina defective medical devices lawyers are here to help you obtain justice and fair compensation for your injuries. Our skilled attorneys handle complex cases, not only in our state but throughout the country.
Please call 888-302-7546 and schedule a free case evaluation by a South Carolina defective medical device attorney, or fill out our contact form today. McGowan, Hood & Felder, LLC, proudly serves clients from offices conveniently located throughout North and South Carolina.