In 2015, the FDA issued a national safety communication linking heater-cooler devices used in open-heart surgery to at least a dozen nontuberculous mycobacterial (NTM) infections in patients. In 2016, another safety communication was issued – this one linking the Sorin Stockert 3T heater-cooler system directly to NTM infections.
A faulty design with the Stockert heater-cooler system allows bacteria – including Mycobacterium chimaera (M. chimaera), the bacteria that causes NTM infections – to colonize within the machine itself. These bacteria can then be sprayed in a fine mist through the system’s exhaust vent and into the chest cavity of the patient being operated on. So far, the CDC has linked this issue to more than 90 adverse reactions and at least 12 deaths, though they are not sure if NTM infections are the cause or simply a contributing factor to fatal complications.
Hospitals in at least 16 states have begun sending letters to open-heart and chest surgery patients who may have been exposed to M. chimaera in the operating room. If you receive one of these letters it is essential that you visit your healthcare provider immediately for testing. NTM infections can take up to five years to show symptoms, making it important that even those who are not showing signs of the infection take precautions.
Symptoms of NTM Infection
Symptoms of NTM infection include:
- Night sweats
- Blood in the phlegm
- Weight loss
- Loss of appetite
- Diminished energy
Treatment for NTM infections can prove incredibly difficult as this infection tends to be resistant to most antibiotics. Nonetheless, diagnosing the infection prior to symptoms may be useful in preventing fatal complications.
We can Help
If you have undergone open-heart surgery – even if you have not received an NTM infection warning letter from a hospital – you may have been exposed to M. chimaera. If you have been exposed and an infection develops, you have cause to take legal action against Sorin (now LivaNova), the company that manufactures the Stockert heater-cooler system.
The Los Angeles defective medical device attorneys at Kirtland & Packard are here to help you get justice. With decades of combined experience and a proven record of holding negligent medical companies accountable for the damages they cause, we are prepared to take your case as far as needed to ensure you are awarded the full compensation you deserve.