Personal Injury Blog

Half a Million Open Heart Surgery Patients at Risk

Over Half a Million Open Heart Surgery Patients at Risk of Deadly Infection

A contaminated medical device commonly used during open heart surgery puts over half a million patients at risk for a deadly bacterial infection. At least 28 cases have already been identified in the United States and numerous infections have also been reported in Europe. The device – the Sorin Stockert 3T Heater-Cooler System – has been reported to transmit bacteria into patients during surgeries, particularly open heart surgeries.

What is a heater-cooler device?

The heater-cooler device is a piece of medical equipment which is used during cardiac surgery to keep a patient’s organs and circulating blood at a specific temperature during the operation. Heater-cooler devices are used in an estimated 250,000 heart-bypass procedures in the United States every year. About 60 percent of these procedures used the Sorin Stockert 3T Heater-Cooler Device that has been linked to the infections.

Lawsuits against manufacturer are increasing

Lawsuits involving the Stockert 3T Heater-Cooler System state that the manufacturer – LivaNova PLC (formerly Sorin Group Deutschland GmbH) — failed to warn hospitals and doctors of the increased risk of infections caused by the device cardiothoracic surgeries.

The company has received complaints about patient deaths related to the infections and the devices since January 2014, according to the Food and Drug Administration (FDA). The FDA also reported that there is strong evidence that the devices were contaminated at a single source, at the company production facility in Germany. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have notified hospitals and doctors about the potential link between the heater-cooler devices and infection. Thousands of patients in the United States have also been notified regarding potential exposure to the contaminated heater-cooler devices.

In 2015, the manufacturer notified hospitals to update cleaning instructions for the machines. However, the FDA found the new guidance was inadequate in reducing the risk of infection. In December of 2015, the FDA placed an import alert on the devices, to restrict the import of the devices into the United States.

Exposed patients should seek legal counsel right away

The Leonard Legal Group is a leading personal injury firm experienced in medical product liability. Attorneys Scott G. Leonard advocates for victims of faulty or dangerous medical products and have a proven track record of success. If you or a loved one has been had surgery using the Sorin Stockert 3T Heater-Cooler Device, contact our office today at 973-984-1414 or online to arrange for a confidential consultation to discuss your case.