Federal agencies have warned that patients who have recently undergone open-heart surgery could be at risk for a fatal infection due to flawed medical equipment. Over 60 percent of open-heart procedures use the defective Stöckert 3T heater-cooler device in surgeries, and Tennessee’s own Vanderbilt University Medical Center has sent letters to at least 400 patients, warning them of their possible exposure to a fatal hospital-acquired infection.
In 2015, the U.S. Food and Drug Administration (FDA) issued a warning letter about the Stöckert 3T, also known as the Sorin 3T, saying it had received reports of severe infections after surgery. In October 2016, both the FDA and the Centers for Disease Control and Prevention (CDC) issued warnings to both patients and hospitals, confirming that the device had been linked to Mycobacterium chimaera (M. chimaera) infections in Iowa and Pennsylvania. Hospitals have been urged to alert any patients who had open-heart surgical procedures between January 2012 and November 2016 about the risk of infection.
How Does the Stöckert 3T Heater-Cooler Cause Infections?
The Stöckert 3T heater-cooler system is made by LivaNova PLC, formerly known as Sorin Group Deutschland. It regulates a patient’s body temperature during surgeries that stop the heart from beating and blood from flowing during procedures. The device circulates a controlled circuit of water to maintain the temperature of the patient’s body, bypass machines, oxygenators, and other surgical equipment. It is thought that the devices were originally contaminated in the factory in Germany where they were manufactured. The bacteria lived and grew in the water tanks, which then spread through the air into the sterile surgical room, potentially inhabiting surgical tools, implants, and the patient’s body cavity.
M. chimaera is a species of nontuberculous mycobacterium (NTM) that is commonly found in soil and water. Normal environmental exposure to M. chimaera rarely poses a health risk to people with healthy immune systems, but can be fatal to patients who have been exposed to the bacteria during surgery. As a result, people who have undergone open-heart surgery should be aware of the conditions:
- Symptoms. The symptoms of an NTM infection can vary widely and can take months or years to develop. The most telltale sign of infection is pain, redness, heat, or an oozing wound at the surgical site. Other possible signs of NTM infection include fever, nausea, vomiting, abdominal pain, muscle pain, joint pain, weight loss, fatigue, and night sweats.
- Diagnosis. As the symptoms may be hard to spot, diagnosis of NTM infections can be overlooked, delaying proper treatment until the infection has spread widely. Hospitals do not normally screen patients for M. chimaera or other NTM bacteria after surgery, and only order blood cultures on patients for these types of bacteria when the patient is immunosuppressed or has infection symptoms that cannot otherwise be explained. Patients who have undergone heart surgeries should ask their hospitals and surgeons if the Stöckert 3T was used in their surgeries, and should request that their blood be tested for the presence of bacteria. Patients may need to have laboratory cultures of their blood every few weeks to rule out infection, as M. chimaera grows slowly and may not be detected in the first blood draw.
- Treatment. M. chimaera infections are difficult to treat as well as diagnose. There may be several different medications used to kill the infection, many of which are themselves toxic to patients. In addition, patients who received implants such as a heart valve or a graft may need the implant removed and replaced, as the implant itself will have bacteria growing on it.
If you have suffered complications due to a recent cardiopulmonary bypass surgery, contact our office today to speak with attorney John L. Griffith about how to begin your claim. We can investigate whether the Stöckert or Sorin 3T device was used in your procedure, and can tell you the next steps to take to get you justice and compensation for your losses.