LivaNova Heater-Cooler Devices Cause Patient Infections
The U.S. Food and Drug Administration (FDA) recently issued a Safety Communication on Nontuberculous Mycobacterium (NTM) infections associated with LivaNova Heater-Cooler devices. Symptoms of an NTM infection may include a combination of the following: fever, pain, night sweats, joint pain, muscle pain, weight loss and fatigue. Patients who have had open heart surgery should seek medical care if they are experiencing symptoms.
New information indicates some LivaNova Stöckert 3T heater-cooler devices, used during cardiac surgical procedures, might have been contaminated during manufacturing which could put patients at risk for life-threatening infections.
LivaNova is a London-based medical device manufacturer; the company develops devices used for cardiac surgery and cardiac rhythm management. Heater-cooler devices are commonly used during cardiac surgical procedures to warm and cool a patient’s blood during cardiopulmonary bypass.
Joe Lyon is a highly-rated and experienced Cincinnati, Ohio personal injury attorney who has represented individuals nationwide in medical device and cardiac incident cases.
According to the U.S. Centers for Disease Control and Prevention (CDC), patients who have undergone open heart surgeries since 2012 may be at risk of the life-threatening NTM infection.
During the use of the LivaNova devices, NTM-contaminated water evaporates or gets sprayed into the air of the operating room. It can then get into a patient’s open chest during the surgery.
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year. Heater-cooler units are a critical part of these surgeries because they help keep a patient’s circulating blood and organs at a specific temperature. Approximately 60 percent of heart bypass procedures performed in the U.S. utilize the LivaNova devices associated with these infections.
This week the federal agencies updated their warnings based on recent reports of infections in patients who had undergone cardiothoracic surgeries using the 3T heater-cooler units. According to a recent CDC report: “Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger.”
The CDC has confirmed infections in 28 heart surgery patients in the United States. At least 12 patient deaths have been reported worldwide. Some patients were diagnosed almost four years after surgery. The infection is particularly dangerous because it is so difficult to detect. To date, these are the six hospitals that have reported infections in the United States:
• WellSpan York Hospital
• Penn State Hershey Hospital
• Penn Presbyterian Medical Center
• University of Iowa
• Mercy Medical Center (Iowa)
• Spectrum Health Medical Center (Michigan)
Because heater-cooler devices can be extremely difficult to disinfect once contaminated, the CDC recommends hospitals continue using the device only if following the manufacturer’s latest recommendations for sterilization.
In a statement, the FDA said data “strongly suggests” that contamination occurred at the production facility, affecting models made before September 2014. Health officials say design flaws didn’t take into account how difficult the equipment is to clean.
A recent CDC lab report show bacteria from the 3T heater-cooler devices match bacteria found in patients in several states. These results build on previous evidence that suggests the bacteria contaminated these devices during the manufacturing process, making LivaNova responsible for the reported deaths.
Last year, the company notified hospitals to update cleaning instructions for the machines. But the FDA found the new guidance to be inadequate for reducing the risk of infection. In December, the agency placed an import alert on the devices.
The Stöckert 3T heater-cooler devices have been available in the United States since 2006. The FDA estimates there are close to 2,000 devices in the United States.
Patients who have been exposed to NTM bacteria through open-heart surgery can develop general and nonspecific symptoms that can often take months to develop. As a result, diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat. To make the problem more complex, infections can only be diagnosed by detecting the bacteria by laboratory culture.
Symptoms of NTM lung disease can be classified into two categories: symptoms that mainly affect the lungs and symptoms that affect the whole body. NTM disease is more common in individuals with underlying lung disease or weak immune systems. The most common respiratory symptoms of NTM lung disease are:
• Persistent cough
• Coughing up blood (hemoptysis)
• Shortness of breath
• Low-grade fever
• Night sweats
• Weight loss
During the past year, the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have notified hospitals and doctors about the link between LivaNova devices and infection. Recently, completed laboratory testing has provided strong evidence that the machines were contaminated at a single source during their production. That means many more machines could be contaminated with the bacteria than have been identified so far, placing thousands more patients at risk.
Pennsylvania’s Department of Health has confirmed 21 cases of infections related to the machines. So far, eight hospitals in four states have notified about 15,000 of their patients who underwent an open-chest procedure. In February, 2016, a class action complaint was filed against LivaNova.
If you or a loved one have suffered an infection after a cardiac operation, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.