FDA's Failure to Monitor Infections Tied To Heart Surgery Device

While modern medicine increasingly uses automated machines and devices to treat a wide variety of illnesses, the equipment itself can sometimes be linked to dangerous or even fatal issues. The public relies on federal regulators to adequately monitor these types of issues and ultimately ensure patient safety, but when that oversight fails, the consequences can be deadly.

That's exactly what's happening with the Sorin 3T heater-cooler system, a medical device primarily used during open heart surgery and tasked with the crucial function of controlling a patient's body temperature. Reports of debilitating, and sometimes deadly, nontuberculous mycobacteria infections linked to contaminated heater-cooler devices first came to light in 2012. But it wasn't until 2015 that the FDA took notice and issued a public Safety Communication about the high risk of the devices. Currently, 79 cases of patients infected by the Sorin 3T have been reported to the FDA. Of those cases, 12 have been fatalities and the numbers will certainly rise.

This month, the CDC also released a warning of the risk of severe bacterial infection in open heart surgery patients from the Sorin 3T. Although armed with evidence of dangerous issues linked to the Sorin 3T in years prior, both the CDC and the FDA only first warned about the potentially contaminated device last year, with the FDA also just recently releasing updated guidance on preventing the spread of infections from the device.

The Sorin 3T works by circulating water to regulate the temperature of patients during surgery, and the device uses three separate water tanks to warm up or cool down the equipment. The recent infections revolve around waterborne pathogens attacking patients through "aerosolization," where lethal bacteria is able to grow inside the device, and then becomes aerosolized through the device's exhaust fan. The deadly germs can float into the patient's open chest or into the implantable heart valve. This puts patients, especially those with compromised immune systems like heart valve or transplant patients, at an increased risk of becoming infected.

The risk to compromised patients is high. Approximately 60 percent of U.S. hospitals who perform heart surgeries currently use the Sorin 3T, and five other manufacturers sell similarly designed heater-cooler devices also prone to contamination. Considering that the infections caused by the device grow slowly and sometimes don't even trigger symptoms for months or years, the FDA's slow reaction and poor oversight has exposed a yet unknown amount of patients to potentially deadly consequences.

As the number of patients who have been affected by these severe infections due to contaminated devices multiplies, the victims and their families are filing lawsuits and seeking justice in court. At PBC, we believe that these cases are a perfect example of how the FDA's current system to identify and respond to critical deficiencies in medical devices isn't sufficient.

If you or a loved one has had cardiothoracic surgery sometime over the last few years and you've since been diagnosed with an infection, contact us to consider taking legal action. Our team has significant experience in medical device cases and takes pride in protecting the safety of vulnerable patients. We will tirelessly advocate on your behalf.