If you received a letter warning about a contaminated heater-cooler unit used in your open-heart surgery, you may be at risk of contracting a nontuberculous mycobacteria (NTM) infection and should contact your doctor immediately.
Why Did I Receive A Warning Letter After My Open Heart Surgery?
On June 1, 2016, the Food and Drug Administration (FDA) advised hospitals to determine a method for patient follow-up and surveillance due to the elevated risk of contracting an infection after open-heart surgery. The elevated risk was assigned to patients whose open-heart surgeries involved a Sorin Stöckert 3T heater-cooler, also known as a LivaNova 3T heater-cooler unit, contaminated with a rare nontuberculous mycobacterium called Mycobacterium chimaera (M. chimaera) that can cause deadly infections.
On October 13, 2016, the Center for Disease Control and Prevention (CDC) announced its laboratory tests had matched NTM bacteria found in open-heart surgery patients to bacteria found in contaminated 3T heater-cooler devices. After announcing this finding, the CDC advised hospitals to notify patients who underwent an open heart surgery involving a contaminated heater-cooler unit that they are at risk of contracting an NTM infection.
As a result, warning letters were sent out to patients nationwide.
What is M. Chimaera?
M. chimaera is a bacteria commonly found in soil and water throughout the world. When an open heart surgery patient is exposed to M. chimaera through a contaminated heater-cooler unit, the bacteria can cause devastating injuries and potentially even result in death. However, an open heart surgery patient exposed to M. chimaera through a contaminated heater-cooler unit may not experience symptoms for months or even years after surgery. The median amount of time post-surgery that symptoms occur is 18 months; however, symptoms have occurred 3 months to even 5 years after the surgery.
According to the CDC, the risk of post-surgical NTM infection is in the range of 1 in 100 patients to 1 in 1,000 patients in hospitals where at least one contaminated heater-cooler unit or infection have been identified.
It is important to be aware of the symptoms associated with an M. chimaera infection and contact a medical professional immediately if you experience them. Below is a list of possible NTM infection symptoms:
- Fatigue
- Fever
- Pain
- Redness, heat, or pus at surgical site
- Muscle pain or aches
- Joint pain
- Night sweats
- Unexplained weight loss
- Abdominal pain
- Nausea
- Vomiting
- Chronic cough
- Septic shock (sepsis)
- Endocarditis (heart lining infection)
- Coughing up blood (hemoptysis)
- Pulmonary disease (lung infection)
- Inflammation of lymph nodes (lymphadenitis)
- Abscesses in abdomen, aorta, or heart valve
How did the Heater-Cooler Units Become Contaminated?
M. chimaera has been discovered in water from Sorin Stöckert 3T heater-cooler units used around the world. More importantly, the bacteria was found in unused heater-cooler units at a LivaNova manufacturing site in Germany and in water samples from the same manufacturing site. The bacterial strains from the manufacturing site matched those found in patients diagnosed with serious infections after 3T heater-cooler units were used in their open-heart surgeries, indicating that the heater-cooler units were contaminated during assembly.
LivaNova is the company that manufactures the Sorin Stöckert 3T heater-cooler units. At the time the contaminated heater-cooler units were discovered, LivaNova accounted for the manufacturing of 60% of the heater-cooler units used in cardiac surgeries in the United States—there are 250,000 open heart surgeries in the U.S. every year—and was also a major supplier of the heater-cooler units for cardiac surgeries worldwide.
What Does a Heater-Cooler Do in Open Heart Surgery?
Heater-cooler units regulate a patient’s body temperature during open-heart surgery.
The heater-cooler unit contains two water tanks and a system of tubing. One tank contains warm water that keeps the patient warm during surgery through indirect thermal transfer (the transferring of heat) to a warming blanket. The second water tank contains cold water which is used to indirectly cool the cardioplegia solution—what slows or stops the heart during surgery.
However, if the water within the tanks becomes contaminated, then the bacteria is aerosolized (converted into a spray or vapor within the air), enters the operating room, and there is risk of the bacteria entering the patient and causing an infection.
Do I have a Heater-Cooler Infection Case?
If you or a loved one has suffered an infection after an open heart surgery, contact one of the defective medical device lawyers at Goldenberg Lauricella for a free heart surgery infection lawsuit consultation. We have over 30 years of experience bringing justice to victims of negligent medical device manufacturers. Let us deliver the Gold standard advocacy you deserve.