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FDA Warns Of Infection Risk Associated With Open-Heart Surgery Equipment

coronary artery bypass grafting

LivaNova PLC's Heater-Cooler System is at center of safety alert

Earlier this year, the Food and Drug Administration issued a safety communication warning patients who have undergone cardiothoracic surgery of a potentially deadly infection risk.

The target of the safety alert is the Stӧckert 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH). Heater-cooler systems are used during surgical procedures such as open-heart surgery to keep the patient's blood and organs at a specific temperature during the procedure.

In order to maintain temperature control, the heater-cooler device uses a water tank attached to a closed-circuit system that circulates temperature-controlled water to warming and cooling blankets or heat exchangers. If this water becomes contaminated with bacteria, there is a significant safety risk to the patient. Although the water itself does not come into contact with the patient, it can aerosolize inside other parts of the device and travel through the device's exhaust vent, exposing the patient to infection.

According to the Centers for Disease Control and Prevention, a quarter of a million heart bypass procedures using heater-cooler devices are performed nationwide every year, and about 60 percent of those procedures use the devices that have been associated with risk of infection. That means hundreds of thousands of patients may be at risk.

Serious injuries and delayed-onset symptoms make these cases difficult

The specific infection identified by the FDA warning is caused by a bacterium called Mycobacterium chimaera, which is typically found in soil and water. While M. chimaera rarely causes illness in healthy people, it can be exceptionally dangerous for people who are undergoing major surgery. The problem is that exposed patients typically develop general, nonspecific symptoms - and those symptoms can take months to become obvious. Some of those symptoms include:

  • fatigue
  • fever
  • pain
  • redness, heat, or pus at the surgical site
  • muscle pain
  • joint pain
  • night sweats
  • weight loss
  • abdominal pain
  • nausea
  • vomiting

Moreover, there is no test to determine whether a person has been exposed, and infections can only be detected by lab culture - a process that can require up to two months because the bacteria grow so slowly. That means patients who have been exposed to a serious, potentially deadly infection may be left searching for answers - and dealing with extensive medical treatment - for an extended period of time.

According to information compiled by the CDC, patients who had valves, grafts, ventricular assist devices or other prosthetic products implanted in their bodies are at higher risk of infection, as are heart transplant patients.

Liability in these infection cases may rest with the manufacturer

While this is an emerging issue with ongoing research, the available information indicates that the manufacturer may be responsible for this risk of infection. Laboratory tests conducted by the CDC and National Jewish Health showed that the same bacteria found on 3T heater-cooler devices were also found in cultures from surgery patients in several states. Moreover, previous evidence from Europe indicated that the devices may have been contaminated with M. chimaera when they were manufactured in Germany.

Injury cases arising from defective medical devices such as these are covered under the legal field of product liability. In order to hold the manufacturer liable, a product liability attorney needs to show that the manufacturer caused illness or injury through a defect in the design, manufacture or marketing of their product. In this case, although more information is needed to know for sure, it appears that a manufacturing defect may be to blame, as the medical devices may have been contaminated with dangerous bacteria due to inadequate quality controls when they were manufactured.

It's also possible that the risk of infection has been aggravated in some cases by medical professionals who did not follow appropriate cleaning and disinfection procedures. If that's the case, the patient could potentially have grounds for a medical malpractice lawsuit against the hospital where the surgery was performed.

Legal cases arising from infections due to dangerous products

Because of the legal and medical complexities of these cases, it's critically important for patients who have undergone heart surgery to seek legal counsel as soon as they see signs of infection. An attorney with experience handling product liability claims can review documents, evaluate medical records and take legal action against the device manufacturer or any other responsible parties.

Damages (financial compensation) recovered in such a lawsuit or settlement can pay for medical expenses, lost wages and other costs endured by the patient as a result of the infection, as well as non-economic losses such as pain and suffering. Likewise, family members who have lost loved ones to a deadly infection can pursue damages through a wrongful death claim. Because of the complexity of such cases and the amount of research required - as well as applicable statutes of limitations - patients who seek counsel right away are more likely to obtain a positive outcome.

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