Stockert 3T Heater-Cooler System is under fire for heart infections, after use in heart by-pass and valve surgeries.
As I had previously reported, the manufacturers of the Stockert 3T Heater-Cooler System also known as the Sorin 3T Heater-Cooler System, are exposed to personal injury and product liability lawsuits.
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 Mycobacteria chimaera bacteria, which has been associated with life threatening infections that may present months or years following open heart surgery.
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 non-tuberculous mycobacterium (NTM) during surgery.
These NTM infections are a significant health risk, and the signs and symptoms can occur up to four years after exposure.
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.”
FDA and CDC Findings
The FDA and CDC are reporting that the Stockert 3T heater-cooler devices were contaminated with a bacteria called Mycobacterium 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.
The CDC is recommending heart surgery patients who are experiencing the following symptoms to seek medical attention:
- Night sweats
- Muscle aches
- Weight loss
- Unexplained Fever
South Dakota 3T Heater-Cooler System lawsuit
Recently, Duane Eisenberg from South Dakota, filed a personal injury and product liability lawsuit claiming that a 3T Heater-Cooler system used during an aortic valve replacement caused M. chimaera infection.
According to Eisenberg, he underwent routine aortic valve replacement in June 2015, but after his surgery he developed signs and symptoms of infection over a period of several months.
In November 2016, he was diagnosed with a failing aortic valve, had to undergo a second aortic valve replacement, and receiving long term antibiotic treatment for the M. chimaera infection.
Eisenberg alleges that the aortic valve replacement bacterial infection led to multiple organ failure, weakness, and kidney dialysis.
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.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor 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.