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Heater-Cooler Devices Complications

In recent years, some heater-cooler devices used during open-chest surgery have been linked to serious bacterial infections, and in some cases death, in certain patients. Contaminated heater cooler devices used during the open-chest surgical procedures can expose patients to a family of bacteria called nontuberculous mycobacterium (NTM), especially the species Mycobacterium chimaera. Those patients may suffer serious injuries, even death, due to heater-cooler device complications. 1 2

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Experienced complications related to a heater-cooler device?

Investigations into reported infections found that all the patients diagnosed with a Mycobacterium chimaera infection had undergone open-heart surgery using a Sorin Stockert 3T heater-cooler device. The bacteria that had infected patients were the same type found in Stockert 3T heater-cooler devices in Sorin’s manufacturing plant in Germany — a type of nontuberculous mycobacterium (NTM). 3 4

Laboratory testing in 2015 linked the invasive bacteria to contaminated Stockert 3T heater-cooler devices. These heater cooler devices were manufactured by Sorin Group Deutschland GmbH, in Germany, now known as LivaNova PLC. 5 6

According to the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA), nontuberculous mycobacterium infections can be severe. 7 8

The Heart and NTM Infections

According to the FDA, the NTM infections linked to heater-cooler devices are often aggressive, but may not cause symptoms until years after their initial surgery (known as a long latency period). Unlike the “classic” presentation of NTM infection, which typically affects those with weakened immune systems, is transmitted via inhalation and affects the lungs, NTM infections linked with heater-cooler devices occur in those with a history of open cardiothoracic surgery, who often have well-functioning immune systems, and are not infected via their lungs. 9

The infections are “deep seeded within the heart.” Patients were exposed during their open-heart surgical procedures. 10

Regulatory agencies have traced these Mycobacterium chimaera infections to contamination in the water reservoirs of heater-cooler devices. Patients were exposed to these bacteria through a process called aerosolization. 11 12 13

The contaminated water in some heater-cooler devices can vent outside of the heater-cooler device, which means that the air in the operating room can become contaminated. 14

The FDA described this process as “a forceful rush of escaping gas from the [heater-cooler devices] creating fine droplets carrying NTMs that then burst and are aerosolized.” 15

Nontuberculous Mycobacteria (NTM)

Nontuberculous mycobacteria (NTM) are found in the environment, often in soil and water. This type of bacteria represent more than 180 different species and subspecies. 16

Healthy people moving about in the environment generally do not become infected with nontuberculous mycobacteria (NTM). However, patients undergoing open-heart surgery who are exposed to nontuberculous mycobacteria during their surgeries may be at risk of developing a serious infection. 17

NTM Infection Symptoms

According to the FDA, possible NTM infection symptoms may include: 18

  • Fatigue.
  • Fever.
  • Pain.
  • Redness, heat, or pus at the surgical site.
  • Muscle and joint pain.
  • Night sweats.
  • Weight loss.
  • Nausea.
  • Vomiting.

Just because you have these symptoms does not necessarily mean you have a nontuberculous mycobacterial infection. However, if you underwent an open-heart surgical procedure and are experiencing these types of symptoms, even if they are occurring several years after your surgery, you may want to speak with your health care provider. 19 20

The CDC has concluded that roughly 60% of heart bypass surgeries performed in the U.S. have used heater-cooler devices linked to nontuberculous mycobacterial infections. Patients who underwent medical procedures where they had a valve or prosthetic device implanted in their chest may face a greater risk of developing a nontuberculous mycobacterial infection after having been exposed to these bacteria via heater-cooler devices during surgery. 21

NTM Treatments

NTM treatments are available. However, one of the potential complications with heater-cooler device-induced NTM infections is that nontuberculous mycobacteria can be very slow growing. Patients may not develop symptoms until months or years after surgery. Getting a correct diagnosis can take even longer; because the infections do not present as typical NTM infections do. Therefore physicians may not be able to recognize heater-cooler-induced NTM infections. 22

Patients undergoing open-heart surgical procedures face the increased risk of developing “deep seeded, valvular and bloodstream infections” due to NTM exposure and infection. NTM infections may turn into serious bloodstream infections, known as NTM sepsis. 23

Anyone who has undergone an open-chest surgery in which cardiopulmonary bypass was used in recent years should pay attention to possible NTM infection symptoms. 24

Doctors treat patients with NTM infections with combinations of antibiotics. Sometimes NTM treatments last for months or years. 25

In some instances, patients who developed an NTM infection after undergoing an open-chest procedure in which a heater-cooler device was used may need to undergo additional surgery. If an NTM infection is not treated, it can be fatal. Some patients have died even after being diagnosed. 26 27

Notifying People at Risk for NTM Infections

In recent years, hospital personnel, the CDC, and FDA have notified thousands of patients across the U.S. about their possible exposure to NTM bacteria via open-chest surgery requiring use of a heater-cooler device. 28 29 30

Both the FDA and CDC are continuing to caution health care providers and patients about the risk of nontuberculous mycobacteria exposure via heater-cooler devices. The sooner patients with NTM infections are diagnosed, the sooner they can begin appropriate treatment. 31 32

NTM Infections and Sepsis

NTM infections can be quite serious, sometimes escalating to bloodstream infections, or sepsis, or requiring subsequent surgeries due to heart valves or other tissues being affected. 33

Sepsis, also known as systemic inflammatory response syndrome (SIRS), is serious and potentially life-threatening. 34

Symptoms of sepsis include: 35

  • Decreased urine output./li>
  • Fast heart rate.
  • Fever.
  • Hypothermia, extremely low body temperature.
  • Shaking and chills.
  • Warm skin or skin rash.
  • Confusion or delirium.
  • Hyperventilation (rapid breathing).

Problems with Heater-Cooler Devices

Heater-cooler devices are used during open-heart surgeries and other procedures to heat and cool a patient’s blood and internal organs. Heater-cooler devices have water tanks that deliver “temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed circuits.” 36

The water in the circuits itself does not come into direct contact with patients. Instead, contaminated water can enter other parts of the device or be vented outside of the heater-cooler into the air. 37 38 39

Once this NTM-contaminated vapor enters the operating room, the room is no longer sterile. Patients can be directly exposed to the contaminated air and water droplets of cooling air. 40

Patients may develop nonspecific symptoms of bacterial infection weeks, months, or years after their exposure to NTM via heater-cooler devices. Because these symptoms are not specific, patients may not make the connection to their open-heart surgery. 41 42

A correct diagnosis of an NTM infection can be missed or delayed. This misdiagnosis or delay can mean the infection is harder to treat. 43

  1. Perkins, K.M., et al. (2016, October 14). Morbidity and Mortality Weekly Report (MMWR). Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States. Retrieved from https://www.cdc.gov/mmwr/volumes/65/wr/mm6540a6.htm?s_cid=mm6540a6_w
  2. U.S. Food & Drug Administration. (2018, June 12). Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication. Retrieved from https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm610394.htm
  3. Perkins, K.M., et al. (2016, October 14). Morbidity and Mortality Weekly Report (MMWR). Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States. Retrieved from https://www.cdc.gov/mmwr/volumes/65/wr/mm6540a6.htm?s_cid=mm6540a6_w
  4. U.S. Food & Drug Administration. (2018, June 12). Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication. Retrieved from https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm610394.htm
  5. Perkins, K.M., et al. (2016, October 14). Morbidity and Mortality Weekly Report (MMWR). Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States. Retrieved from https://www.cdc.gov/mmwr/volumes/65/wr/mm6540a6.htm?s_cid=mm6540a6_w
  6. U.S. Food & Drug Administration. (2018, June 12). Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication. Retrieved from https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm610394.htm
  7. Centers for Disease Control and Prevention. (2018, April 17). Healthcare-associated Infections. Contaminated Heater-Cooler Devices. Retrieved from https://www.cdc.gov/hai/outbreaks/heater-cooler.html
  8. FDA Executive Summary. (2016, June). Prepared for the June 2-3, 2016 meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee. Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM503716.pdf
  9. Ibid.
  10. Ibid.
  11. Ibid.
  12. U.S. Food & Drug Administration. (2018, October 19). FDA’s Ongoing Investigation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492590.htm
  13. U.S. Food & Drug Administration. (2018, June 12). Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication. Retrieved from https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm610394.htm
  14. FDA Executive Summary. (2016, June). Prepared for the June 2-3, 2016 meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee. Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM503716.pdf
  15. Ibid.
  16. American Lung Association. (2018, April 4). Lung Health & Diseases. Learn about Nontuberculous Mycobacteria (NTM). Retrieved from http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/nontuberculosis-mycobacteria/learn-about-ntm.html
  17. Centers for Disease Control and Prevention. (2016, October 13). CDC Newsroom. Contaminated Devices Putting Open-Heart Surgery Patients at Risk. Retrieved from https://www.cdc.gov/media/releases/2016/p1013-contaminated-devices-.html
  18. U.S. Food & Drug Administration. (2017, December 4). Heater-Cooler Devices: Information for Patients. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492585.htm
  19. Johns Hopkins Medicine. (n.d.). News and Publications. Announcement About Heater-Cooler Units Use in Cardiac Bypass Surgery. Retrieved from https://www.hopkinsmedicine.org/news/stories/open-heart-surgery-announcement.html
  20. FDA Executive Summary. (2016, June). Prepared for the June 2-3, 2016 meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee. Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM503716.pdf
  21. Centers for Disease Control and Prevention. (2016, October 13). CDC Newsroom. Contaminated Devices Putting Open-Heart Surgery Patients at Risk. Retrieved from https://www.cdc.gov/media/releases/2016/p1013-contaminated-devices-.html
  22. FDA Executive Summary. (2016, June). Prepared for the June 2-3, 2016 meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee. Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM503716.pdf
  23. Ibid.
  24. U.S. Food & Drug Administration. (2017, December 4). Heater-Cooler Devices: Information for Patients. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492585.htm
  25. Ibid.
  26. Ibid.
  27. Centers for Disease Control and Prevention. (2018, April 17). Healthcare-associated Infections. Contaminated Heater-Cooler Devices. Retrieved from https://www.cdc.gov/hai/outbreaks/heater-cooler.html
  28. Perkins, K.M., et al. (2016, October 14). Morbidity and Mortality Weekly Report (MMWR). Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States. Retrieved from https://www.cdc.gov/mmwr/volumes/65/wr/mm6540a6.htm?s_cid=mm6540a6_w
  29. U.S. Food & Drug Administration. (2018, October 19). FDA’s Ongoing Investigation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492590.htm
  30. FDA Executive Summary. (2016, June). Prepared for the June 2-3, 2016 meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee. Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM503716.pdf
  31. Perkins, K.M., et al. (2016, October 14). Morbidity and Mortality Weekly Report (MMWR). Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery — United States. Retrieved from https://www.cdc.gov/mmwr/volumes/65/wr/mm6540a6.htm?s_cid=mm6540a6_w
  32. U.S. Food & Drug Administration. (2018, June 12). Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication. Retrieved from https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm610394.htm
  33. FDA Executive Summary. (2016, June). Prepared for the June 2-3, 2016 meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee. Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM503716.pdf
  34. Cleveland Clinic. (2015, November 25). Sepsis. Retrieved from https://my.clevelandclinic.org/health/diseases/12361-sepsis
  35. Ibid.
  36. U.S. Food & Drug Administration. (2018, March 26). Heater-Cooler Devices. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/
  37. U.S. Food & Drug Administration. (2015, October 21). Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication. Retrieved from http://wayback.archive-it.org/7993/20170722215713/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm
  38. U.S. Food & Drug Administration. (2018, October 19). FDA’s Ongoing Investigation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices. Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/cardiovasculardevices/heater-coolerdevices/ucm492590.htm
  39. U.S. Food & Drug Administration. (2018, October 19). Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems: FDA Safety Communication. Retrieved from https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623725.htm
  40. FDA Executive Summary. (2016, June). Prepared for the June 2-3, 2016 meeting of the Circulatory Devices Panel of the Medical Devices Advisory Committee. Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices (HCD) during Cardiothoracic Surgery. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM503716.pdf
  41. Centers for Disease Control and Prevention. (2016, October 13). CDC Newsroom. Contaminated Devices Putting Open-Heart Surgery Patients at Risk. Retrieved from https://www.cdc.gov/media/releases/2016/p1013-contaminated-devices-.html
  42. U.S. Food & Drug Administration. (2018, October 19). FDA’s Ongoing Investigation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices. Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/cardiovasculardevices/heater-coolerdevices/ucm492590.htm
  43. Centers for Disease Control and Prevention. (2016, October 13). CDC Newsroom. Contaminated Devices Putting Open-Heart Surgery Patients at Risk. Retrieved from https://www.cdc.gov/media/releases/2016/p1013-contaminated-devices-.html