Dozens of infections and several deaths have been linked to heater-cooler machines that blow bacteria onto patients during open heart surgery. It can take years before patients are correctly diagnosed because mycobacteria is slow-growing.
Need a Texas Heater-Cooler Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with an infection, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: Heater Cooler Recall
In February 2017, LivaNova (Sorin) recalled the FlexTherm Heater Cooler, a machine that is nearly identical to the 3T Heater Cooler suspected of causing infection outbreaks.
What is a Heater-Cooler Device?
Heater-cooler devices are machines that regulate the temperature of patients during open heart surgery (cardiopulmonary bypass). Each device consists of a water tank that provides temperature-controlled water to an external heat-exchanger or a warming/cooling blanket.
LivaNova Stӧckert 3T HeaterCooler
LivaNova manufactures the Stӧckert 3T Heater-Cooler. It is used in about 60% of hospitals that perform open-heart surgery in the United States, which translates to roughly 150,000 patients per year.
What is the problem?
Water in a heater-cooler device does not directly contact a patient. However, bacteria can grow in the water tanks. When the water evaporates, bacteria can “aerosolize” from the device’s exhaust vent and spray onto the patient during surgery, causing a life-threatening Mycobacterial infection. Here is a video:
List of Heater-Cooler Infection Outbreaks
Six hospitals in Michigan, Pennsylvania, and Iowa have reported outbreaks. Over 13,000 patients were notified of exposure and 32 infections were reported. The outbreaks include:
- Wellspan York Hospital – 1,300 notified; 12 cases; 10/1/11 to 7/24/15
- Penn State Hershey Hospital – 2,300 notified; 5 cases; 11/5/11 to 11/5/15
- Penn Presbyterian Medical Center – 1,100 notified; 4 cases; 10/1/13 to 12/17/15
- University of Iowa – 1,500 notified; 3 cases; 1/1/12 to 1/22/16
- Mercy Medical Center in Iowa – 2,600 notified; 2 cases; 7/1/12 to 7/1/16
- Spectrum Health Medical Center in MI – 4,500 notified; 2 cases; 1/1/12 to 11/10/15
FDA Safety Warnings
In January 2016, FDA warned that the instructions for cleaning a heater-cooler device may not be adequate and they are blocking imports until the problem is fixed.
In October 2015, the FDA reported 32 adverse events involving infections or bacterial contamination of a heater-cooler device between January 2010 and August 2015.
In June 2016, the FDA warned about the risk of infections from the Stӧckert 3T heater-coolers made by Sorin. The infections may not appear for months or years after patients undergo open-heart surgery.
In August 2016, health officials in Australia reported the nation’s first case of an NTM infection in a patient who underwent open heart surgery in 2015.
In October 2016, the FDA said evidence “strongly suggests” the 3T heater-coolers were contaminated at the same place and asked hospitals to “strongly consider” using another heater-cooler during open-heart surgery.
Symptoms of Infection
It can take years for symptoms of an NTM infection to appear because the bacteria is very slow-growing. In some cases, patients did not develop symptoms of an infection until several months or up to 4 years after their surgical procedures. Symptoms may include:
- Redness, heat or pus at the incision site
- Night sweats
- Muscle aches
- Joint pain
- Unexplained fever
- Nausea, vomiting
Non-Tuberculosis Mycobacterium Infections
Non-Tuberculosis Mycobacterium (NTM) is commonly found in the environment, such as soil and tap water. Diagnosis of an NTM infection is often delayed because the bacteria is slow-growing and early symptoms are non-specific. It can take years before the infection is correctly diagnosed. Fortunately, once diagnosed, it is usually treatable.
Need a Heater-Cooler Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Heater-Cooler lawyers for a free lawsuit review.