A heater-cooler contamination lawsuit has been filed in Philadelphia Court of Common Pleas. The plaintiff, a Philadelphia man, alleges the heater-cooler device used by surgeons at Penn Presbyterian Medical Center exposed him to bacteria resulting in him suffering a slow growing infection and eventual stroke. The heater-cooler devices used during open heart surgeries and the methods used to clean them are coming under increasing scrutiny by health officials.
The plaintiff in the Philadelphia lawsuit underwent valve surgery late in 2014. Immediately following the surgery, he claims things were fine; however, after a few months, he started to experience symptoms he now relates to the infection he alleges came from the heater-cooler device. Now, he’s taking legal action against the manufacturer of the device as well as Penn Presbyterian Medical Center.
The heater-cooler device at issue in this lawsuit is intended to maintain the blood temperature of patients on a heart-lung bypass machine. The infection, called nontuberculous mycobacteria (NTM for short), believed to be associated with the use of the device may take months or years to cause symptoms in an unknowing patient. NTM infections are especially dangerous for this reason – patients may not develop signs or symptoms until years after their exposure. NTM infections may manifest themselves in a number of ways including endocarditis, surgical site infection, or abscess and bacteremia. Other clinical manifestations have included hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis.
So far, the FDA says it has received notice of 79 infections worldwide related to a device similar to the one at issue in the Philadelphia lawsuit. There are an estimated 20 Pennsylvania patients known to have contracted infections after exposure to the heater-cooler devices in various hospitals including Penn State Hershey Medical Center, WellSpan York Hospital, and Penn Presbyterian.
A representative for Penn Presbyterian wouldn’t comment on the heather-cooler lawsuit directly but did note “the devices in question were removed from our hospitals to address the concerns raised.”