Widely Used Medical Device May Cause Severe Bacterial Infections in Open Heart Surgery Patients
The Sorin Stockert 3T heater-cooler system, a medical device used to regulate a patient’s body temperature during open heart surgery, may be to blame for life-threatening bacterial infections.
The U.S. Food and Drug Administration (FDA) recently updated a Safety Communication regarding Mycobacterium chimaera (M. chimaera) infections associated with the use of the 3T heater-cooler in U.S. patients who have undergone cardiothoracic surgeries (surgeries involving the heart, lungs, esophagus and other chest organs).
M. chimaera is a type of nontuberculous mycobacterium (NTM) known to grow slowly, which, over time, can cause debilitating health problems and even death. The Safety Communication states the bacteria may have contaminated the devices at the manufacturing facility and were distributed worldwide.
The Centers for Disease Control and Prevention (CDC) is advising patients who have had open heart surgery to seek immediate medical care if they are suffering symptoms linked to infections, such as fatigue, night sweats, muscle aches, weight loss, or unexplained fever.
How the 3T Heater-Cooler Causes Bacterial Infections
Keeping a patient warm or cool during cardiothoracic surgeries may help optimize medical care and improve patient outcomes. Heater-cooler devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits.
Although the water in the circuits does not come into direct contact with the patient, it’s possible for bacteria to grow in the water tanks of the device. Contaminated water can enter other parts of the device, or transmit bacteria through the air via the device’s exhaust vent, spread into the operating room, and flow into the sterile surgical field – infecting the patient.
Symptoms of Infection
Symptoms of an NTM infection can take months to develop, leading to delayed diagnosis – sometimes for years – making the infections difficult to treat. These infections may require hospitalization, and could even lead to death. Symptoms include:
- Difficulty breathing
- Persistent cough or cough with blood
- Redness, heat, and/or pus at the surgical site
- Muscle or joint pain
- Night sweats
- Weight loss
- Abdominal pain
Serious Bacterial Infection after Open Heart Surgery? Contact Sokolove Law Now
If you or a loved one developed a severe bacterial infection after open heart surgery, or if your loved one’s infection resulted in death, you may be entitled to compensation. Lawsuits have already been filed across the country. Contact Sokolove Law today for a free, confidential legal consultation to learn more about your legal options.