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A product liability lawsuit filed by a Michigan man alleges that a severe infection following aortic aneurysm surgery was caused by a 3T Heater-Cooler System used during the heart procedure, which have been found to be contaminated with a strain of nontuberculous mycobacterium (NTM) known as M. Chimaera.
The complaint (PDF) was filed by Peter Kuhnmuench and his wife, Theresa, in the U.S. District Court for the Eastern District of Michigan on May 31, indicating that a device manufactured and sold Sorin Group and Livanova PLC was the cause of his NTM infection, which was diagnosed several years later.
The 3T Heater-Cooler System is commonly used to control blood temperature during open heart surgery. However, temperature controlled water contained in many devices found in operating rooms nationwide have become contaminated with NTM in recent years, resulting in the bacteria being released into the surgical field through the system’s exhaust.
Kuhnmuench indicates that a 3T Heater-Cooler was used when he underwent an ascending aorta replacement procedure in June 2014, to treat an aortic aneurysm. It was also used in follow-up heart surgeries at least three times, according to allegations outlined in the complaint.
In October 2015, Kuhnmuench indicated to his doctor that he was experiencing muscle stiffness and tenderness around the surgical area. He also complained of fatigue and night sweats, for which medical professionals could find no cause. The problems persisted, however.
It was not until October 2016, when the hospital where he was treated sent out letters warning that it’s 3T System may have been contaminated with M. Chimaera, that Kunmuench and his doctors could determine the cause of his continuing health problems.
He was ultimately diagnosed with an NTM infection, and is still being treated with antibiotics.
His lawsuit indicates that the design for the 3T Heater Cooler system is defective, which increased the risk of microbial contamination.
“Reasonable and feasible alternative designs existed at the time of design, manufacture, and at the time the Sorin 3T System was placed into the stream of commerce, that would have eliminated or vastly reduced the risk of bacterial colonization and transmission to the air and/or patients,” the lawsuit states. “[A]lternative designs… included, but were not limited to, isolating the exhaust from the surgical suite and surgical field, reducing the exhaust rate, utilizing a closed loop exhaust circuit, utilizing an isolated cooling circuit, utilizing disposable parts for the portions of the device that could colonize bacteria, utilizing filters in the cooling loop to remove bacteria, adding clean in place features that could clean and sterilize the cooling loop chemically or with high temperatures on a regular basis, and several other possibilities used alone or in combination.”
3T Heater-Cooler Infection Problems
Kuhnmuench is one of several thousand heart surgery patients who received similar hospital letters about the NTM infection risk over the past year, warning that they should be monitored for signs of problems, which may not surface for months or years after their procedure.
The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
Late last year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera 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.
The 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.