Mycobacterium Chimaera Infection Lawsuits Reviewed for Open Heart Surgery Patients

Harvey Kirk

By Harvey Kirk
Posted November 3, 2016

UPDATE: Saiontz & Kirk, P.A. is no longer reviewing new cases against the manufacturer of the 3T Heater-Cooler. However, potential claims for medical malpractice are being evaluated against hospitals that failed to follow proper safety instructions provided in recent years.

Due to problems with Heater-Cooler Systems used in many operating rooms, a number of open heart surgery patients have developed a severe and potentially life-threatening infection, known as M. Chimaera or Mycobacterium chimaera.

This slow growing infection, which is a type of nontuberculous mycobacteria (NTM), may not result in systems until months, or even years after surgery. However, it can result in severe disability and wrongful death.

Treatment typically involves a combination of antibiotics. However, in some cases the infection is so deep that it can take months or even years of antibiotic treatment to cure. If untreated, these infections can be fatal.

While Heater-Cooler Systems are commonly used during heart valve surgery, vascular grafts and other cardiac procedures, certain devices manufactured prior to September 2014 may have become contaminated. In addition, bacteria may be left in the devices if they are not properly cleaned or filled with safely filtered water. This may result in the release of vapor into the air of the operating room, where exposure to the open chest cavity may cause a Mycobacterium chimaera infection.

Contact the M. Chimaera Infection Lawyers at Saiontz & Kirk, P.A. to determine whether you or a loved one may have a lawsuit.

M. Chimaera Infection Risk Following Heart Surgery

While it appears the manufacturer of certain Heater-Cooler System knew or should have known about the risk of problems following heart surgery, information is just now being discovered by many doctors and patients.

UPDATE: Saiontz & Kirk, P.A. is no longer reviewing new cases against the manufacturer of the 3T Heater-Cooler. However, potential claims for medical malpractice are being evaluated against hospitals that failed to follow proper safety instructions provided in recent years.

In June 2013, a case report published in the Journal of Clinical Microbiology detailed instances where two heart surgery patients who had procedures years apart from each other each developed bloodstream infections caused by Mycobacterium chimaera. Researchers concluded that M. Chimaera infections should be considered during differential diagnosis of patients with biomechanical or mechanical heart valves who present with symptoms similar to endocarditis or septicemia. However, a clear connection to the heater-cooler systems used during these heart procedures was not made at that time.

It was not until M. chimaera bacteria was found in the production line and water supply at a manufacturing facility that the connection started to become more clear for federal health investigators. This resulted in a “corrective action” by the manufacturer, providing instructions for medical providers about how to determine whether the device was contaminated in July 2015. The FDA later classified this action as a Heater-Cooler recall, although the devices remained in place in many operating rooms nationwide.

In another study published in the medical journal Open Forum Infectious Disease in June 2016, researchers noted that ten case reports of disseminated M. chimaera infections linked to heart surgery were published from Europe, and three new cases were described involving infections following aortic graft or valvular surgery within the United States.

That same month, the FDA issued a Safety Communication about the Mycobacterium chimaera infection risk with certain Heater-Cooler systems used during open heart surgery. The agency confirmed that it has received reports of U.S. patients infected with M. chimaera after cardiothoracic surgery involving the device.

As a result of the investigation, the FDA issued an update regarding M. chimaera infections following heart surgery on October 13, 2016, indicating that hospitals should take several steps, including:

  • Immediately remove heater-cooler devices, accessories, tubing and connectors that have tested positive for M. chimaera;
  • Direct and channel heater-cooler exhaust away from the patient and into the operating room exhaust vent;
  • Limit use of certain Heater Cooler Systems manufactured prior to September 2014 unless it is an emergency or life-threatening sitiation and no other heater-cooler system is available;
  • Monitor patients who have undergone coardiopulmonary bypass for signs and symptoms of M. chimaera infections, or nontuberculous mycobacteria (NTM) infections.

Heater-Cooler Heart Surgery Infection Class Action Lawsuits

The Mycobacterium chimaera infection lawyers at Saiontz & Kirk, P.A. are reviewing potential individual cases, as well as Heater-Cooler class action lawsuits for individuals who may have been exposed during heart surgery.

Since these heart surgery infections may not appear for several months or years after the procedure, M. chimaera infections may continue to be diagnosed among individuals who were exposed to these unreasonably dangerous and defective devices. In addition, since individuals and families had no way of discovering the cause of their surgical infection, or even that it may have been caused by the heart surgery, wrongful death lawsuits and prior infection claims can still be brought.

Financial compensation may be available through an open heart surgery infection lawsuit for any individuals who have suffered severe injuries or lost loved ones due to these infections. All cases are handled on a contingency fee basis, which means that there are no fees or expenses unless a recovery is obtained. Request a free consultation and claim evaluation.

13 Comments • Add Your Comments

  • Donald says:

    I had first open heart surgery.aortic valve transplant in 2008 supposed to last 15 years or more my valve died from infection and no one knew what caused it in 2013 Jan 2 I had second valve transplant and had to go to rehab center for 60 days for if antibiotics

    Posted on November 24, 2016 at 3:52 am

  • Evalyn says:

    I underwent open heart in June 2016. I’ve had a very slow recovery due to a lead from my pacemaker tore a hole in my heart in the previous March. It bled into the sac around my heart to five hours before they caught it. So they had to go in and repair my heart from that. Then three months later in had mitral valve replacement and the maze procedure. Also another valve repaired. I received a letter from my cardiologists about the possibility that I could get this infection. I’m scared.

    Posted on December 10, 2016 at 3:15 am

  • lucinda says:

    My husband has had ohsurg 4 years ago at renown2013. He has been vomiting clammy lost muscle mass in matter of 6 months. He has spells and send as though he is dying. I have been hounding his PCP and they stopped seeing him treated us like crap and I have documented it all. Omg hopefully an answer to my nightmare. Testing for it after cardiologist appt. I hope it won’t be too late

    Posted on December 12, 2016 at 12:42 am

  • Roy says:

    I had open heart surgery in July 2015 . Four months ago I started feeling bad! Severe fatigue, muscle ackes, had lost 20 lbs ,night sweats! Joint pain. Then I received a letter from the hospital witch explained how I was feeling. No body wanted to take me serious! All I heard was the chances of you having this are 1 in a thousand. I seen the infectious diseases dr. Well now I am on the antibiotics for at least a year!

    Posted on January 14, 2017 at 4:20 pm

  • Steve says:

    NTM is also found built up inside shower heads. I can be contacted for further comment.

    Posted on February 9, 2017 at 7:02 pm

  • Tiffny says:

    What type of dr did you go to for testing? Did the test cone back positive? Thank you and i will be praying for your speedy recovery!

    Posted on February 13, 2017 at 10:40 am

  • Dianne says:

    I am just frantic! CABG surgery in May, 2015. Released from hospital not fond of an immediately into another and diagnosed with pneumonia for quite some time! Horrible chest and right back pain that has never left. Today I got a letter from hospital where I had surgery informing me that I had been identified via clinical records as a patient who might be affected by this device during surgery which causes NTM. REALLY!!! How does one get tested?

    Posted on March 1, 2017 at 4:18 pm

  • Jan says:

    CHECK OUT THE DENTAL LINES FOR NTM also. See CASES IN ORANGE COUNTY, CA involving a Children’s Dental Clinic. Also, CHECK Water Companies to be sure they provide NTM free water to the customers.

    Posted on March 2, 2017 at 4:57 pm

  • Gavin says:

    I’m from uk had a mechanical valve I’ve received a letter I some times have the fear of dred I’m worried sick no one seem to listen

    Posted on April 19, 2017 at 2:22 pm

  • Rick says:

    My mother had a mytral valve replaced in 2015. She was just diagnosed as having the infection mentioned in this article. She’s really suffering and now on antibiotics for the next 6 months. She’s very scared.

    Posted on July 12, 2017 at 5:20 pm

  • Carol says:

    My husband had replacement valve surgery December 2013 no complications until April 2017. Whilst having a routine diabetic blood test the results were investigated further by our GP due to abnormal results. Admitted to our local hospital for two weeks re admitted weeks later and I had to inform the hospital of the letter we had received March 2017. Cultures were taken and he was transferred to the Hospital where he had had the heart operation. It was not until the end of May when a diagnosis was made. The bacteria was in the bone marrow, blood and then liver. Over the last six months 5 stone in weight loss, 7 different antibiotics taken at the same time causing loss of hearing damage and further damage to liver and kidneys. He has now been told that his life span is a possible 9 months. The valve is working perfectly. My argument is why did the government not notify patients earlier where a culture test could have been done before the bacteria had got to a untreatable stage.

    Posted on November 30, 2017 at 2:32 am

  • Isabel says:

    I have a dear friend who was a marathon runner, very respected professional who went from heart surgery 8 months later hospitalization to 1 year of severe deterioration and now is near death. He was diagnosed with chimaera infection. The cost to the family is insurmountable.

    Posted on June 21, 2019 at 3:49 pm

  • Janie says:

    I recently lost a dear friend to this infection. His decline spanned over 2-3 years as his body began to shut down slowly. It was torture. Do the doctors inform you of the risk of contracting an infection that will take 2 years to kill you. A wrongful death

    Posted on September 21, 2019 at 5:16 pm

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