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Heart Surgery Infection: LivaNova Heater/Cooler Medical Device
Concerns are being raised about infections which are being spread during open heart surgery as a result of contaminated devices and machinery in the operating room. These infections now appear to be more evident than previously thought. This has resulted in the U.S. Centers for Disease Control and Prevention alerting surgeons, physicians and hospitals about the contamination.
Reports indicate that close to 30 cases have been identified in the United States as a result of the infection which is bacterial in nature. In these cases, 4 fatalities may be tied to the contamination and resulting infection. Health officials have indicated that there could be hundreds or thousands of people who underwent the surgical procedure and may now be infected.
The source of the contamination is being tied to certain medical devices, known as heater/cooler devices, which are used during open heart surgery to regulate a patients’ body temperature by keeping it warm, while the heart is kept cool while the procedure is being carried out.
In 2014, the device manufacturer determined that the contamination occurred in its German factory. Steps were taken to ameliorate the situation however the infectious bacteria has been found in machines in a few states, including Iowa and Pennsylvania, as well as in Switzerland. These machines have been linked to infections in these locations. It is believed that the heater/cooler devices, manufactured by UK based LivaNova and identified as a Stockert 3T machine, are used in about 50% of the annual 250,000 bypass operations performed in the United States each year.
Of concern is the significant risk factor involved during open heart surgery where the infection is most apt to occur. The Centre for Disease Control in the US has observed that in hospitals where an infection has been confirmed, the odds were between 1 in 100 and 1 in 1000 that a patient may be at risk of developing the bacterial infection.
The bacteria, identified as Mycobacterium chimaera, is mostly found in ground and water and usually does not result in an illness if exposed to it. However, persons who undergo cardiovascular procedures are usually in a condition where their immune system and bodily defences are low after the procedure and are therefore more likely to develop the infection.
In Canada, an alert has been issued by Health Canada concerning the severe risks of infection as a result of exposure to these contaminated medical devices. On June 21, 2016, Canada’s regulatory body posted an advisory which noted that the manufacturer of the device, LivaNova, had found that quantities of hydrogen peroxide was transferred from the water side to the blood side during procedures and that the quantity exceeded the manufacturer’s allowable limit.
Patients who have had open heart surgery should ensure that they attend at their family physician or a hospital if they experience any adverse effects post-surgery, including sweating at night, aching muscles, general fatigue, loss of weight or fevers.
Wagners is currently researching the issues concerning this medical device and the adverse reports of infections post-surgery which are coming to light. We are reviewing information and documentation that is available and are investigating the prospects of a filing class action proceeding against the manufacturer, LivaNova.
If you or a family member reside in Canada and have had open-heart surgery and have suffered serious complications from exposure to the contaminated heater/cooler device, you may wish to contact our lawyers at Wagners to discuss your situation and the potential for compensation for your medical issues.