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A South Carolina man diagnosed with a rare nontuberculous mycobacterium (NTM) infection following heart surgery has filed a product liability lawsuit against the makers of the 3T Heater-Cooler system, which was used to maintain his blood temperature during the procedure.
The complaint (PDF) was filed by Edward Ray Waddell in the U.S. District Court for the District of South Carolina on April 24, indicating that LivaNova PLC and Sorin Group manufactured and sold contaminated devices, which have been linked to severe and life-threatening NTM infections that surface months or even years after valve replacement surgery, cardiac bypass or other open heart procedures where the 3T Heater-Cooler has been commonly used.
Waddell indicates that he was exposed to a contaminated heart surgery heater-cooler during an aortic valve replacement and cardiac bypass grafting procedure in December 2013. The 3T system was used to regulate the temperature of his blood during the procedure. However, following the procedure, Waddell suffered deteriorating conditions, including a high-grade fever, weakness and developed pneumonia.
It was not until April 2014 that a red rash and bubbling began to appear around the surgical site. He was placed on antibiotics, had to undergo sternal debridement, and was fitted with a wound vac.
Later, Waddell underwent an additional debridement, and also had a pectoralis major muscle flap procedure. The lawsuit indicates that this has severely affected his ability to use his arm.
He was diagnosed with an M. abscessus infection, which is a form of nontuberculous mycobacterium (NTM) infection, which resulted in an aortic aneurysm, according to the lawsuit. Several years later, Waddell indicates that he is still receiving treatment for the heart surgery infection.\
3T Heater Cooler System Infection Risks
Concerns about the heater-cooler infection risk following heart surgeries first emerged in October 2015, when the FDA issued warnings about a large number of adverse event reports received in connection with blood heater-cooler devices.
In June 2016, a panel of experts were convened to evaluated the issue, indicating that at least 34 reports involving NTM infections following heart surgery where heater-cooler systems were used.
Late last year, the federal regulators issued a safety communication warning about contaminated 3T Heater-Coolers, indicating that water tanks used by the devices may spread contaminants to other parts of the system, where they can be released into the air of the operating room.
“If allowed within the operative field, NTM poses a significant health risk to surgical patients and patients with compromised immune systems,” the lawsuit filed by Waddell states. “Because NTM is a slow growing bacterium, it generally takes anywhere from two weeks to four years before manifestation of an NTM infection, which most commonly results in pulmonary or cardiovascular disease.”
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of NTM infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.
Waddell’s complaint is one of a growing number of other NTM infection lawsuits filed nationwide over the 3T Heater-Cooler, alleging that the manufacturers knew about the risk of contamination and failed to adequately warn the medical community, the FDA, and patients of the risks.
Over the coming months, it is expected that additional cases will be filed, as individuals and families learn that problems experienced following heart surgery may be related to the use of a 3T Heater-Cooler.
The FDA is now advising facilities using 3T devices to remove the devices and any accessories from service if they have tested positive for the bacteria, or have been linked to patients who later were identified as infected. The agency also recommends using new accessories, tubing and connectors if using a new heater-cooler device, channeling exhaust from the devices away from patients and into an operating room exhaust vent, and to review the recommendations in the CDC’s health advisory.