In October 2016, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued warnings regarding the risk of infection associated with Stockert 3T heater-cooler units. Moreover, these specialized devices are routine during open heart surgeries and other procedures. Additionally, federal agencies report that some of the devices may have become contaminated with bacteria, which can pose a dangerous or fatal threat to heart patients. Hence, it is important for patients to be aware of the potential risks and to seek immediate medical evaluation if they have recently undergone open heart surgery.

Suppose you or a loved one has recently been diagnosed with bacterial infection after surgery. In that case, we encourage you to speak with one of our injury attorneys about your situation. Furthermore, you may be eligible to receive compensation. Therefore, contact Gallon, Takacs & Boissoneault Co., L.P.A. at 419-843-6663 for a complimentary consultation.


What is the problem with Stockert 3T Heater-Cooler units?


Heater-cooler devices form an integral part of open heart surgeries. According to the CDC, over 250,000 individuals undergo heart bypass procedures involving these devices annually. These machines utilize cool water and fans to maintain a safe and specific temperature for the patient’s blood, heart, and body throughout the procedure.

However, the issue arises from contaminating some devices with Nontuberculous Mycobacteria (NTM) bacteria during the manufacturing process in Germany. NTM bacteria, commonly found in soil and tap water, are typically harmless to healthy individuals. However, immunocompromised patients can result in severe, life-threatening infections.

The FDA reports that water samples drained from the 3T devices and air samples collected while the devices were in operation were tested. The results strongly suggest that the 3T heater-cooler units are the source of M. chimaera, a type of NTM contamination. In contaminated devices, the fans can blow the bacteria inside the machine into the surgery room and the patient’s body.


How do I know if I have been infected with NTM bacteria?


Roughly 60 percent of all heart bypass procedures use a heater-cooler device associated with NTM bacterial infections. The FDA has received dozens of reports of patient infections associated with heater-cooler devices. In hospitals where at least one infection has been identified, the CDC estimates patients’ risk of getting an infection between one in 100 and one in 1,000.

Diagnosis is challenging because it can take months for the bacteria to cause symptoms. Plus, the symptoms are non-specific, so neither patients nor doctors may realize at first that the symptoms have anything to do with an NTM infection. CDC Deputy Director Dr. Michael Bell explains, “If you are a couple of years out from your surgery, and you aren’t having any symptoms, then you don’t need to worry about this particular issue.” However, if your surgery was more recent, you should go to your clinician if you are having any of the following symptoms which could be related to an NTM infection:

  • Night sweats
  • Fatigue
  • Fever
  • Redness, heat, or pus at the surgical site
  • Muscle or joint pain
  • Weight loss
  • Nausea or vomiting


How are NTM bacterial infections treated?


If you test positive for an NTM bacterial infection, your doctor will likely initiate your treatment by administering a round of strong antibiotics. However, this specific type of bacteria can exhibit resistance to treatment, and as a result, some patients may necessitate prolonged treatment lasting months or even years. Moreover, although rare, patients who acquire an NTM infection following heart surgery may require additional surgical intervention. Furthermore, if left untreated, an NTM infection can potentially be fatal.


What remedies do patients have if they have developed an NTM infection?


Infected patients (and family members in fatal cases) have already initiated personal injury and class action lawsuits against the manufacturer. Moreover, if you have received a diagnosis of an NTM infection after surgery involving a heater-cooler device, you may qualify to file a claim and seek compensation for your losses. Furthermore, the link between the devices and NTM infections is strongly supported by evidence, making the likelihood of a successful outcome in your case excellent. Additionally, the device has not only received warning reports from the CDC and FDA but has also been subject to a national recall.

Notably, you may qualify for damages to cover various aspects, including:

– Current and future medical expenses associated with the infection
– Miscellaneous expenses resulting from your injuries
– Loss of wages
– Household services
– Pain and suffering
– Decreased quality of life
– Death benefits, such as funeral expenses, loss of income, and loss of support (in fatal cases)

How do I pursue compensation for a post-surgery NTM infection?


If you have a serious infection related to surgery, take the first step by speaking to an injury lawyer about your case to pursue compensation. Gallon, Takacs & Boissoneault Co., L.P.A.’s attorneys would be delighted to assist you. We will review your case, investigate the facts, and determine if your case meets the criteria for filing a liability claim.

Our firm deeply cares about our clients’ situations, understanding the physical, financial, and emotional devastation that a serious infection can cause. If a defective device or medical mistake caused your illness, we can help you hold the appropriate party liable and fight for maximum compensation on your behalf.

Contact our office today at 419-843-6663 to schedule a free consultation and learn more.