Two more heart-surgery patients are accusing the University of Pennsylvania Health System of failing to prevent dangerous infections linked to a widely used device called a heater-cooler.
One of them, Robert Gerngross, underwent valve-replacement surgery two years ago at Penn Presbyterian Medical Center and still feels lethargic and short of breath due to the infection, an attorney for both patients said Thursday.
The other, Marisa Karamanoogian, had heart surgery at the Hospital of the University of Pennsylvania a year ago and also still suffers infection-related symptoms, including hearing loss, attorney Michael F. Barrett said. A third such patient sued the Penn Medicine system in October, after undergoing heart surgery at Penn Presbyterian.
Barrett filed pre-complaint motions on behalf of Karamanoogian and Gerngross in the Court of Common Pleas in Philadelphia this month, seeking the name of the manufacturer of the heater-cooler devices used in each case.
Penn officials declined to comment, citing the pending litigation.
Heater-coolers have been blamed in dozens of post-surgical infections worldwide, including in Delaware and New Jersey. They are used in connection with the heart-lung bypass machine, and contain circulating water that is used to heat and cool the patient’s blood during surgery.
The water does not come into contact with the patient, but infection-control experts have been warning for several years that the devices may nevertheless pose a risk, as droplets of water can become aerosolized from a vent in such devices. The devices are used in hundreds of thousands of surgeries each year, so the relatively few cases reported represent a low risk of infection, federal officials say.
Most such infections reported to the U.S. Food and Drug Administration have involved a type of heater-cooler called the Stöckert 3T, and several area health systems which used that model, including Penn, have replaced it. Federal health officials say the 3T device may have been contaminated during the manufacturing process.
Hospitals initially were slow to link any infections to heater-coolers because they involve a type of slow-growing microbe called nontuberculous mycobacteria, which can take months to yield symptoms.
Karamanoogian’s infection was caused by a fast-growing variety of the bacteria, according to her legal motion. A member of the Delanco school board, the 39-year-old mother of three underwent heart-valve surgery in February 2016 and began to experience pectoral pain and other infection symptoms the following month, the motion states.
Gerngross, 60, an electrical contractor in Erdenheim, had valve-replacement surgery in February 2015 but did not start to feel sick until more than a year later, in August 2016. He felt weak and lethargic and lost 40 pounds, and was diagnosed with an infection that eventually required a second valve replacement, according to his legal motion.
A special session on heater-coolers was held in Houston this month at the annual meeting of the Society of Thoracic Surgeons.
Physician Keith Allen, of St. Luke’s Hospital in Kansas City, told participants that the bacteria in question were widespread in the environment and are very hard to remove from a heater-cooler device once it becomes contaminated, according to MedPage Today.
“We’ve only begun to scratch the surface, even though it has been going on for 2 years,” he said.