Non Tuberculous heart infections following surgery, may be linked to a commonly used device known as the Stockert 3T Heater-Cooler System manufactured by Sorin Group Deutschland (now LivaNova).
This device is under intense investigation for for possibly causing serious and deadly heart infections after use in heart by-pass and valve surgeries.
Non Tuberculous Heart Infections Following Surgery
Non Tuberculous Mycobacteria (NTM) infections related to these devices have been reported in five countries so far according to a recent medical report, and according to experts caused by bacterial contamination in the devices.
When the heating-cooling units are used in heart bypass surgery, bacteria from the device are aerosolized from the water tanks and pushed into the air by the device’s exhaust fan. The aerosolized bacteria can then enter the patient’s open surgical site in the operating room.
What is Nontuberculous Mycobacteria?
Nontuberculous mycobacteria are naturally-occurring organisms found in water and soil. NTM lung infection occurs when a person inhales the organism from their environment. Most people do not become ill but for some susceptible individuals, a slowly progressive and destructive disease can occur.
Non Tuberculous Mycobacteria Lawsuits
According to lawsuits being filed in the federal court system, the contaminated Sorin 3T Heater-Cooler Systems are blamed for spreading of Mycobacterium (M.) chimaera and other non-tuberculosis mycobacteria infections.
Bacterial contaminated vapors may be released by the devices, attacking patients with compromised immune systems and open chest cavity during the surgery. Infected patients have complained about Mycobacterium chimaera or Mycobacterium abscessus infections.
What is the problem with Stockert 3T Heater-Cooler device?
The device uses water as a cooling medium, and the water that becomes contaminated with bacteria may be released into the air, entering the surgical site. The device is linked to the spread of NTM during surgery.
Nationwide attention became focused on the device, after heart surgery patients received hospital warning letters last year, noting that they may have been exposed to the risk of severe NTM bacterial infections due to the use of certain 3T Heater/Cooler devices.
FDA Warning: Stockert 3T Heater-Cooler
Stockert 3T Heater-Cooler safety warnings have been issued by both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) alleging that the devices are linked to catastrophic NTM infections.
The Stockert 3T Heater-Cooler System is made by LivaNova PLC (formerly Sorin Group Deutschland) and is sometimes labeled the “Sorin 3T Heater-Cooler System.”
According to the FDA, “there is potential for contaminated water to enter other parts of the device and aerosolize, (the bacteria can be transmitted in the air) through the device’s exhaust vent into the environment and to the patient.”
Hospitals are being recommended by the FDA to consult their hospital infection control officials to perform the appropriate follow up measures and report events of device contamination to the manufacturer and to the FDA via MedWatch.
FDA and CDC Findings
The FDA and CDC are reporting that the Stockert 3T heater-cooler devices were contaminated with a bacteria called M. chimaera when they were manufactured in Germany. M. chimaera contamination at the manufacturing facility was found during tests in September 2014.
The FDA issued its first safety communication in October 2015 when it reported that the federal agency had received 32 Medical Device Reports (MDR) concerning patients that had developed infections allegedly caused by heater-cooler devices.
In June 2016, the FDA warned that M. chimaera infections were linked to the 3T heater-cooler devices made by LivaNova. The FDA issued its most recent warning on October 13, 2016 to provide doctors and hospitals with additional recommendations on how to prevent the spread of infection.
If you or someone you know succumbed to a NTM infection following open-heart surgery after a 3T Heater-Cooler device was used during the procedure, please call us for further information at 214-390-3189. Dr Shezad Malik Law Firm is investigating Mycobacterium (M.) chimaera and other non-tuberculosis mycobacteria (NTM) infections after heart or heart valve surgery.