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Contaminated Heater-Cooler Devices Putting Open-Heart Surgery Patients at Risk

by John Gomez | Last Updated: October 20, 2016

A frightening new heart surgery risk is endangering patients around the country. The U.S. Centers for Disease Control and Prevention (CDC) recently published a warning to patients and healthcare providers of the potential for infection from open-heart surgeries using particular devices. If you’ve recently undergone open-heart surgery and are suffering infection-related symptoms, you may have grounds for a lawsuit. Here’s what you need to know about this public health threat.

What’s the Health Risk Associated with Heater- Cooler Devices?

In 2014, doctors diagnosed 15 open-heart surgery patients with a rare infection. These patients had complained of pain in their chests – a normal complaint after such surgeries. Upon closer inspection, however, doctors made a disturbing discovery. The source of the pain wasn’t normal at all, but a very rare type of infection. The infection is non-tuberculosis mycobacteria (NTM). This microbe is common in water and soil and is typically harmless. When present within the chest cavity during open-heart surgery, however, NTM can be deadly.

A strain of NTM on prosthetic heart valves or inside open chest cavities makes patients fatally sick, exhibiting symptoms of infection. Symptoms for infected patients include muscle ache, fatigue, night sweats, weight loss, and fever. The infection is life-threatening because of it’s location within the chest. Patients infected with NTM after surgery can experience chest pain, difficult breathing, and pus leaking from the surgical site.

While treatment for NTM infections after open-heart surgery is possible, patients may be too sick to withstand the it, as it requires several powerful drugs over the course of six or more months.

An NTM infection is so rare that many nurses had never seen it before. After four of the 15 diagnosed patients passed away from complications due to the NTM infection, public health departments launched an investigation. The South Carolina Public Health Department found traces of the microbe on heater-cooler devices – the machines hospitals use to regulate body temperature during some heart and lung operations. The Health Department didn’t confirm that the heater-coolers caused the infection, but the attorneys of injured patients believe this connection is clear.

Assigning Responsibility for the Contamination

Since the S.C. Public Health Department discovery, organizations in several other states (including Pennsylvania and Iowa) have reported the same findings. One heater-cooler manufacturer and several federal agencies have stated that these devices – which keep patient’s blood and organs the correct temperature during life-saving surgeries – are capable of harboring NTM and spraying it through the exhaust vents. A heater-cooler machine could spray NTM, which grows in water, throughout an operating room and into patients’ open chest cavities.

From 2010 to February 29, 2016, the U.S. Food and Drug Administration (FDA) received 180 health reports relating to heater-cooler devices around the globe. Sixteen hospitals in 10 different states in America reported at least 45 NTM infections. Of these patients, nine have died. The CDC issued a warning following information that points to LivaNova PLC Stöckert 3T heater-cooler devices as the culprit for causing the infection. The CDC reports that something may have contaminated these devices during manufacturing, causing the subsequent patient infections.

About 60% of all heart bypass procedures use heater-cooler devices during surgery. The FDA has named this contamination a serious public health concern. The CDC urges clinicians and patients to stay alert to this ongoing risk, evaluating potential cases of NTM infection quickly and effectively.

As doctors and researchers continue to discover more facts about this harmful bacterial strain outbreak, stay informed and make educated decisions regarding open-heart surgeries.

If you or a loved one has recently had an open-heart or lung procedure followed by symptoms of infection, talk to a San Diego product liability lawyer today.


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