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What Is A Heater Cooler System Lawsuit?

 As early as 2002, lawsuits have been filed against heart cooler manufacturers due to a design fault.





This fault meant that thousands of people were developing infections, while in hospital. The system that was designed to help regulate their temperature during surgery was making them ill.


Doctors and hospital managers were noting a correlation, and it’s this pattern that allowed them to pinpoint the culprit. 


If you’ve developed an infection after surgery, you could have been a victim of the design fault too. Contact https://trulaw.com/ for advice on your case and learn if you are entitled to compensation.


How Heater Cooler Systems Work

A heater cooler system controls the temperature of your blood while you’re in open heart surgery. 


Without this technology, your heart will not be able to handle being outside of the body. The change in temperature alone could make your body go into shock.


The system circulates warm water around your body using tubes. This allows you to stay warm. The water doesn’t enter your body. It says within the tube. However, the ventilation system means water particles are transmitted into the air.


If the water used is contaminated, polluted air particles will be around your body during surgery.


When testing the equipment and hygiene of an operating room, Laboratory Pathogens Specialist John Rihs found that many devices had tested positive for M. Chimera. In fact, the machine had been infected for months.


Although those cleaning the operating room were acting correctly, John Rihs found that the machine itself was difficult to disinfect. The error was with the manufacturers, not the medical staff.


Stockert 3T Officially Linked To Infections

The machine linked to a high infection rate was the Stockert 3T Heater Cooler System. In the US around 250,000 open heart surgeries are performed every year and the Stockert 3T is the most commonly used heart cooler system for these operations.


Once Laboratory Pathogens Specialist John Rihs' research was announced, the FDA and CDC created warnings for those going through heart, lung, or liver surgeries.


If any symptoms of infections arose, they were instructed to go to hospital. Fighting off the infection early meant having a higher chance of survival.


Stockert 3T Heater Cooler Systems are still in operation despite this discovery. The FDA and CDC couldn't shut down this production as a suitable replacement wasn’t available. The risk of injection was less severe than no surgery at all.


M. Chimaera - A Deadly Bacteria

M. Chimaera isn’t normally associated with infections. Instead, it’s usually found in untreated water or soil. 


Because the heater cooler system uses water as a temperature mechanism, it might be left in the machine for long periods of time. Although new water will be added to keep the system running, residuals of past water will still exist in the system. This is how M. Chimaera grows and continues to stay within the machine.


When a person is undergoing surgery, their body is vulnerable. Developing an infection or contracting bacteria during this time can be deadly.


M. Chimaera is already a deadly bacteria, so in this circumstance, the infection will likely be fatal. In fact, half of the patients diagnosed with M. Chimaera after open heart surgery do not survive the illness.


One reason for the fatal ending comes from a lack of specific symptoms. This means a patient may be living with the bacteria for months before they pass away or receive treatment. Misdiagnosis or failure to report an illness are the two main reasons for the delay.


If you develop a fever after your open heart surgery, contact your doctor.


Other symptoms may include:

  • Vomiting

  • Coughing Blood

  • Persistent Coughing

  • Difficulty Breathing

  • Lethargy 

  • Muscle or Joint Pain

  • Heat or Redness Around The Incision

  • Night Sweats


The FDA And CDC’s Suggestions For Hospitals

Because 60% of US hospitals use Stockert 3T, the FDA investigated the machine.


In 2014, they confirmed that the production line contained traces of M. Chimaera, as did the water supply the manufacturer was using. Since then the FDA charged the company and encouraged a full-scale disinfection program.


By 2016 the program was completed, and since then the FDA has not become aware of a recurring issue.


In 2016 the CDC conducted its own review and found that 1 in 500 people was at risk of infection still. As the situation is still going, the CDC has released a health alert for hospitals.


This alert is designed to help health providers and hospitals communicate and identify any patients that might be at risk. These patients are then sent a letter about the risks and symptoms of M. Chimaera.


Hospitals have been told to follow the updated rules and regulations around cleaning heater cooler systems, and to ensure they are using the most up-to-date version of the machine.


Summary

Although M. Chimaera has been identified in hospitals that use the Stockert 3T Heater Cooler System, the machine nor the company has been banned from use.


If you suspect your hospital hasn’t been complying with the new advice from the CDC you could be due compensation.


If you notice any symptoms after your surgery, contact your doctor immediately.


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