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Heater-Cooler Devices

Each year, hundreds of thousands of people in the United States undergo open-chest, or open-heart, surgeries of one kind or another. A growing concern is that in recent years some patients have developed a certain type of serious bacterial infection and died after undergoing an open-chest procedure due to bacterial contamination of a type of device use during their surgeries. (1) (2)

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Experienced complications related to a heater-cooler device?

Contaminated heater-cooler devices used during open-heart procedures have been pinpointed as being to blame. Heater-cooler devices are medical devices that regulate the temperature of a person’s blood and internal organs while they are undergoing cardiothoracic surgery; the devices are used during many types of open-chest surgical procedures. (3) (4)

Contaminated Heater-Cooler Devices

Investigations have indicated Sorin Stockert 3T heater-cooler devices may have become contaminated in the company’s manufacturing plant in Germany. When used later during open-chest surgeries, those devices may have exposed patients to infectious bacteria. (5) (6)

Investigations have found that patients in both Europe and the U.S. who developed infections were infected with the same bacteria found in the Sorin plant in Germany. Those bacteria are Mycobacterium chimaera, a type of nontuberculous mycobacteria (NTM). These NTM infections reported in patients with a history of cardiothoracic surgery are very often different from other “typical” NTM infections that infect the patients as pulmonary (lung) infections. As the U.S. Food and Drug Administration (FDA) explains, these heater-cooler device-linked NTM infections are “non-pulmonary; they are invasive, deep seeded within the heart at times of heart valve replacements.” (7) (8)

Regulatory agencies are continuing to investigate these infections. The agencies are advising anyone who develops symptoms of a bacterial infection and underwent an open-heart procedure in the past few years to consult a health care professional as soon as possible. The FDA has also notified patients in seemingly good health who have undergone surgery requiring cardiopulmonary bypass that they should ask their health care providers during their next wellness visit “if you require further testing or monitoring for possible exposure to NTM.” (9) (10)

Heater-Cooler Devices Lawsuit

Dozens of heater-cooler devices lawsuits have been filed against the Sorin Group Deutschland GmbH, Sorin Group USA, Inc., and LivaNova PLC. (11)

The heater-cooler devices lawsuits claim Sorin’s heater-cooler devices exposed patients to infectious NTM. The specific brand of heater-cooler device that seems to be the main culprit is the Sorin Stockert 3T heater-cooler device. (12)

In February 2018, the U.S. Judicial Panel on Multidistrict Litigation consolidated more than three dozen cases into a single multidistrict litigation (MDL) in the Middle District of Pennsylvania. An MDL allows similar individual lawsuits to be filed in one jurisdiction so the legal process can be expedited by consolidated proceedings. (13)

Regulatory agencies believe the company’s manufacturing plant may have introduced the bacteria into the heater-cooler devices. The heater-cooler devices then became contaminated. (14) (15)

During open-heart surgical procedures in which these heater-cooler devices were used, patients may have been exposed to those bacteria and later developed an NTM infection. Some patients have since died due to developing an NTM infection following their cardiothoracic surgery. (16)

Agencies Issue Warnings About Heater-Cooler Device

Both the FDA and the Centers for Disease Control and Prevention (CDC) have issued warnings about possible dangers of contaminated heater-cooler devices. Investigations now suggest a specific model is to blame: the Sorin Stockert 3T heater-cooler device. (17) (18)

Patients who underwent an open-chest surgery in which a Sorin Stockert 3T heater-cooler device was used may be at risk for developing and being diagnosed with a nontuberculous mycobacterial (NTM) infection, even if several years have elapsed since surgery. By the end of 2015, regulatory agencies were alerting health care providers about potential dangers of heater-cooler devices. (19) (20)

Patients who have undergone these types of procedures in which heater-cooler devices may have been used may be at risk for developing an NTM infection: (21) (22)

  • Coronary bypass.
  • Aortic valve replacement.
  • Mitral valve replacement.
  • Mitral valve repair.
  • Aneurysm repair surgery.
  • Transplant.
  • Pulmonary and tricuspid valve procedures.
  • Cardiac tumor removal.
  • Other procedures involving the heart and major blood vessels.

Heater-Cooler Devices Recall

On August 1, 2014, Sorin Group USA, Inc., wrote a letter to its heater-cooler device customers instructing them to “review the disinfection and monitoring practices and to strictly adhere to the instructions” for use. The FDA categorized this recall as a Class 2 recall. (23)

At that time, the company said 1,618 of the 3T Stockert heater-cooler units had been distributed in the United States. An additional 129 units had been distributed outside the United States. (24)

This letter was the beginning of multiple heater-cooler device recalls and safety alerts to come. Agencies have continued to investigate concerns about heater cooler devices used during open-chest surgical procedures. (25)

Sorin Stockert 3T Heater-Cooler Recalls

In 2014 investigators began looking into concerns related to 3T heater-cooler devices after the FDA began receiving medical device reports about patient deaths from atypical Mycobacterium abscessus infections, some of which occurred in patients who had had cardiothoracic procedures. In 2015, additional patients in the U.S. and others in Europe had developed infections of invasive Mycobacterium chimaera, a type of NTM infection, after undergoing open-heart procedures. (26) (27)

Laboratory tests, including genome sequencing, confirmed concerns about Sorin’s 3T heater-cooler recall and the infectious NTM, leading the CDC to conclude their “results strongly suggest a point-source contamination of Stöckert 3T heater-cooler devices.” (28)

Concerns about the Sorin Stockert 3T heater-cooler device-related infections and recall continued to mount. Regulatory agencies concluded there was a link between “invasive Mycobacterium avium complex, including M. chimaera, infections and exposure to contaminated Stöckert 3T heater-cooler devices.” (29)

On April 20, 2018, LivaNova, which merged with Sorin in 2015, sent a Medical Device Correction to consumers and issued a recall of Sorin Stockert 3T Heater-Cooler Systems. The FDA classified the recall as a Class 2 recall, for all devices less than 10 years old, as they “are suspected of microbial contamination and may contain visible biofilm.” The manufacturers notified consumers that returned, recalled devices would “receive a deep cleaning service…” (30)

The FDA issued an updated Safety Communication on October 19, 2018, to make consumers aware of LivaNova’s Medical Device Correction letter and the newly issued recall. (31)

Regulatory agencies have urged patients who have had open-chest surgery to seek medical care if they are experiencing the following types of symptoms: (32)

  • Persistent pain.
  • Redness, heat, or pus around the chest surgical incision.
  • Night sweats.
  • Muscle aches.
  • Joint pain.
  • Weight loss.
  • Fatigue.
  • Unexplained fever.

NTM Infections Related to Heater-Cooler Devices Can Be Hard to Diagnose

NTM stands for nontuberculous mycobacteria. Nontuberculous mycobacteria are a family of bacteria including 169 different species found in the environment, including soil and water. (33)

People who are susceptible to NTM infections typically have pre-existing conditions such as cystic fibrosis, and transmission occurs due to breathing in the bacteria, leading to pulmonary infection. Unlike this more common situation, however, NTM infection related to heater-cooler devices does not occur due to inhalation, does not appear in the lungs, and may take several years to develop into clinical symptoms. In addition, these heater-cooler-related NTM infections are often “invasive, deep seeded” and have been “traced to the presence of the organism [M. chimaera] in the water reservoirs of heater-cooler devices…” (34)

NTM infections are generally slow growing. Because of this, doctors may not diagnose NTM infections right away. Correct diagnoses can be missed altogether or delayed for years. (35)

Healthy people generally do not become sick when they are exposed to Mycobacterium chimaera and other species of NTM in the environment. However, patients undergoing open-chest surgical procedures may have been exposed via heater-cooler devices, and potentially may become ill with NTM infections. (36)

And, according to the CDC, “Patients who have been exposed to the bacteria through open-heart surgery can develop general and nonspecific symptoms that can often take months to develop.” (37)

Heater-Cooler Contamination

According to the FDA, “There is the potential for NTM bacteria to grow in a water tank in the heater-cooler units.” Typically, the water in heater cooler devices does not make direct contact with patients. (38)

It is possible, however, for contaminated water to move into other areas of the heater-cooler unit or to turn into vapor that is vented out of the unit from its exhaust fan. This process of becoming vaporous and airborne is called aerosolization. (39)

Water droplets can form on the outside of the unit. In addition, “these water droplets containing NTM bacteria may remain suspended in the air, which may increase the chances of entering the patient’s open surgical cavity or contaminating a sterile implant such as a heart valve.” (40)

Heater-Cooler Device Design

Most heater-cooler devices are designed similarly. Generally, they contain one to three large tanks filled with water. Heater-cooler devices are often used along with heart-lung machines during cardiopulmonary bypass procedures. These heart-lung machines take over “the work normally performed by the heart and lungs to assure oxygenated blood is being continuously distributed to all organs…” (41)

These tanks “are either heated or cooled for delivery to heat exchanger(s) or blankets.” Some heater-cooler devices have air and water filters; some do not. Some of these filters may be insufficient to filter out NTM bacteria. (42)

Most heater-cooler devices also have fans. These fans typically cool the heater-cooler device itself or help cool a compressor inside the heater-cooler device. (43)

However, these fans may also make it possible for water contaminated with NTM to become airborne and vent outside the heater-cooler device. This vaporous mist can then spread into the operating room, potentially contaminating the sterile surgical field surrounding the patient. (44)

  1. 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
  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. 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
  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. 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
  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. 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
  8. 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
  9. 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
  10. 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
  11. United States Judicial Panel on Multidistrict Litigation. (2018, February 1). In Re: Sorin 3T Heater-Cooler System Products Liability Litigation (No. II). Transfer Order. MDL No. 2816. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2816-Initial_Transfer-01-18.pdf
  12. Ibid.
  13. Ibid.
  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. 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
  16. Ibid.
  17. 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
  18. 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
  19. 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
  20. 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
  21. 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
  22. 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
  23. U.S. Food & Drug Administration. (2018, May 31). Class 2 Device Recall HeaterCooler 3T. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=150831
  24. Ibid.
  25. 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
  26. Ibid
  27. 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
  28. Ibid.
  29. Ibid.
  30. U.S. Food & Drug Administration. (2018, May 18). Class 2 Device Recall Stockert HeaterCooler System 3T. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164360
  31. U.S. Food & Drug Administration. (2018, October 18). 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
  32. Centers for Disease Control and Prevention. (2015, October 27).Non-tuberculous Mycobacterium (NTM) Infections and Heater-Cooler Devices Interim Practical Guidance. Retrieved from https://www.cdc.gov/HAI/pdfs/outbreaks/CDC-Notice-Heater-Cooler-Units-final-clean.pdf
  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. Ibid
  35. 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
  36. Ibid.
  37. Ibid.
  38. U.S. Food & Drug Administration. (2017, December 4). FDA's Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices. Retrieved from https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492590.htm
  39. Ibid.
  40. Ibid.
  41. 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
  42. Ibid.
  43. Ibid.
  44. Ibid.