For patients or parents who have questions about the heater/cooler device used during open-heart surgery, please call our help line at 321.843.7200 or visit the Centers for Disease Control (CDC) website for more information.
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recently notified health care providers across the U.S. that certain units of a device used during open-heart procedures, the LivaNova PLC Stöckert 3T heater-cooler, have been linked to cases of a rare bacterial infection caused by Mycobacterium chimaera, a species of bacteria known as nontuberculous mycobacterium or “NTM.” While investigations by the CDC and FDA are ongoing, new information indicates that some of these heater-cooler devices were contaminated during the manufacturing process. The notices and warnings issued by the CDC and FDA are widespread across the U.S. because more than 60% of surgeries using a heater-cooler device are performed using the Stöckert 3T device (this number is even higher in pediatric populations).
In an effort to spread awareness of the investigational findings and to share additional information and resources with you, please review the Frequently Asked Questions below:
Frequently Asked Questions
Question #1:
How will I know if I have been infected?
We recommend patients see their physician or a health care professional if they are concerned about being at risk for this infection due to the presence of symptoms of M. chimaera such as unexplained night sweats, muscle aches, weight loss, fatigue and unexplained fever.
Question #2:
What is my risk of infection?
The CDC has indicated the chances of patients being infected with M. chimaera are very low―less than 1 percent.
Question #3:
Am I at risk for infection?
Those who are at potential risk are patients who had open-heart (bypass) surgery at Arnold Palmer Hospital between May 2011 and October 2016. As of now, APH has not had any reported cases of NTM infection among its open-heart surgery patients. It is rare and slow-growing, but as a precaution, we recommend that patients see their physician or a health care professional if they are concerned about being at risk for this infection.
Question #4:
How did these devices get contaminated?
The CDC reports that the devices may have been contaminated during the manufacturing process.
Out of caution and in cooperation with the CDC, we have removed prior models of the heater-cooler device, and a completely different type of unit is being placed for use at Arnold Palmer Hospital. To date, we have not had any reported cases of NTM infection among our open-heart surgery patients.
Question #5:
What is Mycobacterium chimaera?
Nontuberculous mycobacterium (NTM) are types of bacteria often found in soil and water that rarely make healthy people sick.
Question #6:
When did you start using this device and are you still using it?
We started using this device in May 2011. Once the CDC issued the advisory, we stopped using the device and replaced it with a newer model. To our knowledge, that device has not been linked to this type of infection.
Question #7:
Where and when was this device used?
Arnold Palmer Hospital is the only Orlando Health facility where this device was used. It was used during open-heart (bypass) surgery.
Question #8:
Can I give this disease to my family or other people?
No. NTM rarely makes healthy people sick and is not passed from person-to-person.
Question #9:
Why does it take so long to determine if you have the infection?
M. chimaera is a rare and slow-growing bacterium. It can take months or even years for symptoms to appear. Once symptoms become apparent, lab and microbiologic tests may identify the infection.
Question #10:
Why have you waited so long to tell me about my potential risk?
The CDC recently notified us of the possible link between this rare bacteria and the equipment used
during certain cardiac surgeries. While more information continues to emerge, we want to alert parents and patients to raise awareness that will allow for the identification of patients with potential infections as soon as possible.
Question #11:
If I (my child) do have this infection, what are you going to do about it?
If you (your child) are showing any symptoms, we ask that you see your physician or a health care professional to get immediate help and then contact us. To date, APH has not had any reported cases of NTM infections among its open-heart surgery patients.
Question #12:
I’m planning to have cardiac surgery at Arnold Palmer Hospital for Children and I want to know whether or not you’re using the contaminated devices.
We have discontinued the use of this device. We are using a newer model that has not been linked to the infection. We strictly adhere to the manufacturer’s cleaning and maintenance guidelines. We encourage you to discuss with your surgeon or doctor the risk, benefits, and alternatives to the procedure.
Question #13:
Where can I get more information?
If you have questions about your (your child’s) medical records, please call our help line at 321.843.7200. For more information, you may also visit the CDC (https://www.cdc.gov/HAI/outbreaks/heater-cooler.html) or FDA website (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm20082725.htm).
Question #14:
I have not received a letter from anyone. What does that mean?
We have carefully reviewed all of our patient records and notified those we believe need to be aware of the issue. Patients should see their physician or a health care professional if they are concerned about being at risk for this infection.
Question #15:
I am currently an APH patient. Have you notified my physician that I am at risk? If not, how can I get more information about this situation to share with them?
If you have received a letter about this issue from us, you should present that letter to your physician, who can contact us with any questions or concerns s/he may have. If you have not received a letter, you are not at risk. However, if your physician would like to learn more about this issue, s/he can visit the CDC website.