More than two dozen lawsuits allege 25 patients were infected with a potentially deadly bacteria while undergoing open-heart surgery at Kansas City-based University of Kansas Hospital, The Kansas City Star reported March 10.
The lawsuits center around Mycobacterium chimaera, a slow-growing bacteria found in the soil and water. The rare infection is associated with a global outbreak of infections among patients who have undergone open-heart surgery where a heater-cooler device was used. Heater-cooler devices contain pumps that circulate water to regulate a patient’s temperature. If not sterilized properly, the aerosolized bacteria is pushed out of the device by exhaust fans and can enter the patient’s open cavity. Infections can take weeks or years to show symptoms, and symptoms are non-specific, such as fatigue, swelling, persistent cough, fever and nausea.
To date, 31 lawsuits have been filed against the hospital and LivaNova USA, Inc., the company that manufactures the heater-cooler device. Of these, 10 lawsuits are still pending, all filed between October 2020 and February 2024. The rest of the lawsuits were settled confidentially or dismissed, The Star found.
The lawsuits allege that the hospital failed to follow specific recommendations to minimize or eliminate the risk of airborne M. chimaera transmission from the heater-cooler device. They allege the hospital failed to properly disinfect the units and failed to isolate the equipment during surgeries. The lawsuits also allege that LivaNova failed to use reasonable care to design and provide proper instructions for safe use of the devices.
Of the 25 patients allegedly infected with M. chimaera, 11 died and the others are living with life-altering health problems, according to the lawsuits.
A report by the Cambridge University Press found the issue first arose in 2017. The hospital responded by replacing five devices with newer loaner units that LivaNova said had a lower risk of contamination. However in 2019, 11 more patients had M. chimaera infections associated with heart surgeries. Hospital staff and the CDC investigated the causes of the infections and found staff were not properly monitoring or disinfecting the device as recommended by the manufacturer.
Almost all of the patients with pending lawsuits had open-heart surgery in 2019.
“The University of Kansas Health System provides care to patients with complex needs,” Dan Peters, general counsel for The University of Kansas Health System, told The Star. “Our culture and decisions are focused on how best to meet those needs. Based on the information we had at the time, we took the steps we believed were necessary to keep patients safe, while continuing to provide life-saving surgical interventions that otherwise would not have been available without this critical medical device. When we learned about potential impacts of these devices, we proactively reached out to patients who may have been affected to support their needs. Today, the health system has all new devices with a design change that eliminated the previous condition that created the potential for infection.”
LivaNova declined to speak to the specifics on ongoing litigation, but told The Star, “we are vigorously defending the product and company actions in these cases.
“At LivaNova, patient care and product quality remain central to everything we do,” it said. “The Company stands firmly behind the 3T™ Heater-Cooler device, having worked closely with global regulators to mitigate risk and ensure continued clinician access to this critical technology for lifesaving cardiac surgery.”
The first pending lawsuit is scheduled to go to trial on April 13.
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