Heart Surgery may be linked to deadly bacterial infections, with the commonly used Stockert 3T Heater-Cooler System. The device is under fire for serious and potentially deadly heart infections after use in heart by-pass and valve surgeries.
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 (NTM) infections. Injured patients claim that they developed severe bacterial infections after the heater-cooler device was used during heart surgeries.
Bacterial Infections more widespread than initially reported
According to a pre-published new report, bacterial contamination complications may be commonplace, affecting nearly 9 out of every 10 devices in operating rooms.
In a recent study, researchers found that nearly all 3T Heater-Cooler patient warming systems were contaminated with M. chimaera bacteria, may present with signs and symptoms of infections months or years following open heart surgery.
According to the Los Angeles times report earlier this month, there are at least four heart surgery patients who have been sickened by the M. chimaera infection.
What is Stockert 3T Heater-Cooler device?
The device is used to control patient blood temperature during heart bypass surgery, valve surgery and other cardiac procedures.
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 888-210-9693. Our law firm is investigating Mycobacterium (M.) chimaera and other non-tuberculosis mycobacteria (NTM) infections after heart or heart valve surgery.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.