Mycobacterium chimaera infections can cause serious injury, including pneumonia and death. Of particular concern is that patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure, making the infections difficult to detect and diagnose.
A recently published European study1 found a link between:
- M. chimaera clinical samples from several infected cardiothoracic patients;
- Samples from the heater-cooler devices used during these patient’s procedures; and
- Environmental samples from the device manufacturer’s production and servicing facility in Germany.
The FDA acknowledges, “The results of this paper suggest a direct link between the M. chimaera to which the European patients were exposed and became infected during open-chest cardiac surgery, and one specific heater-cooler model – the 3T” (FDA Safety Communication dated June 1, 2016).
“Reports to date suggest there may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used,” according to the FDA.
What is the Stockert 3T Heater-Cooler System?
The Stockert 3T Heater-Cooler System (3T), manufactured by Sorin Group Deutschland GmbH is used during cardiothoracic procedures (heart, chest surgery). The device is intended to provide temperature-controlled water to:
- oxygenator heat exchangers,
- cardioplegia (paralysis of the heart) heat exchangers, and/or
- warming/cooling blankets to warm or cool a patient during cardiopulmonary bypass procedures lasting six hours or less.
Heater-cooler devices like the 3T include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits.
“Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient” (FDA).
Mycobacterium Chimaera Found in Sorin Plant
In testing conducted by the manufacturer in August 2014 (yes, almost 2 years ago), Mycobacterium chimaera contamination was found at the facility in Germany where the Stockert 3T Heater-Cooler System is manufactured:
- On the production line; and
- In the water supply .
Some of the units that were manufactured at this facility were distributed in the United States.
In response to the M. chimaera findings in August 2014, Sorin added cleaning and disinfection procedures to the production line in September 2014. “Samples taken at the same manufacturing facility in June 2015 did not show M. chimaera on the production line, potentially eliminating this as a contamination source,” according to the FDA.
Reports of M. Chimaera in U.S. Patients after Surgery involving Stockert 3T Heater-Cooler System
The FDA has received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery when the Stockert 3T Heater-Cooler System was used during their surgery. In response to these reports, the FDA taking steps to determine if the infections in U.S. patients and M. chimaera isolates from samples taken from the 3T are linked with M. chimaera isolates from European patients who were infected and the M. chimaera previously identified at the 3T manufacturer’s production and servicing facility in Germany.
The FDA has also communicated with health care facilities recommending that, if a Sorin 3T was purchased and used prior to September 2014:
- they inform health care providers who have performed cardiothoracic surgeries that there is a possibility that their patients may have been infected with Mycobacterium; and
- they determine a method for patient follow-up and establish patient surveillance in cases of potential exposure.
If you or a loved one had cardiothoracic surgery, you have not received a notification from your health care provider regarding exposure to M. chimaera via the Sorin 3T, and you are concerned, you should contact your medical provider. If you or your loved one was diagnosed with M. chimaera at any time after surgery (it can take years for symptoms to appear), you should contact a lawyer for a free consultation (click here now) and find out if you have a lawsuit against Sorin. These are extremely complex cases, and the specific facts of your case will determine if you have a case.
FDA Recommendations for Patients
Be aware that:
- In the U.S., cardiopulmonary bypass procedures involve the use of a heater-cooler device;
- The FDA has received reports of patient infections associated with exposure to M. chimaera when a contaminated 3T (heater-cooler device) was used during surgery; and
- There may be an increased risk of infection if you received a heart valve, graft, LVAD or any other prosthetic product/material or had a heart transplant.
If you have undergone cardiopulmonary bypass, be aware of the possible signs and symptoms of infection, which may include:
- difficulty breathing
- persistent cough or cough with blood
- redness, heat, or pus at the surgical site
- muscle pain
- joint pain
- night sweats
- weight loss
- abdominal pain
If you have undergone a cardiopulmonary bypass (heart bypass) procedure and are experiencing any of these signs and symptoms, you should contact your health care provider as soon as possible.
If you are not currently experiencing any changes in your general health, inform your health care provider during your next wellness visit that you have undergone a heart bypass procedure to determine if you require further testing or monitoring for possible exposure to M. chimaera (nontuberculous mycobacterium (NTM)).
1 Haller S, Hӧller C, Jacobshagen A, Hamouda O, Abu Sin, M, Monnet, DL, Plachouras D, Eckmanns, T. Contamination during production of heater-cooler units by M. chimaera potential cause for invasive cardiovascular infections: results of an outbreak investigation in Germany, April 2015 to February 2016. Euro Surveill. 2016;21(17):pii=3025. DOI: http://dx.doi/10.2807/1560-7917.ES.2016.21.17.30215
2Sommerstein et al. 2016. Transmission of Mycobacterium chimaera from heater-cooler units during cardiac surgery despite an ultraclean air ventilation system. Emerging Infectious Diseases.
3Garvey et al. 2016. Decontamination of heater-cooler units associated with contamination by atypical mycobacteria. J. Hospital Infection.