Heater-cooler machines keep patients warm during open-heart surgery. Unfortunately, they can also blow bacteria into the air in an operating room and cause deadly infections. Dozens of infections outbreaks have been reported.
What You Can Do & How We Can Helpm
The Schmidt Firm, PLLC is currently accepting heater-cooler induced injury cases in all 50 states. If you or somebody you know has been diagnosed with an infection after heart surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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.
Recently Had Open Heart Surgery?
You may have been exposed to a risk of infections from a heater-cooler device. About 250,000 people undergo open-heart surgery in the United States every year, and the Stӧckert 3T has a 60% market-share in hospitals, according to the CDC.
How a Heater-Cooler Works
Heater-cooler devices help regulate the temperature of a patient’s blood during open heart surgery (cardiopulmonary bypass). The machines consist of a water tank connected to a heat-exchanger or blanket used to keep patients warm.
What is the problem?
Water in the system never directly contacts the patient. However, when the water evaporates, bacteria in non-sterile water can “aerosolize” from the exhaust vents and blow onto a patient, resulting in a deadly infection with Mycobacterium chimaera.
Watch this video of the problem from the CDC:
Study: Nearly All Heater-Coolers Contaminated
In January 2017, researchers in Denmark warned that most heater-cooler units made in the last 8-10 years were likely contaminated with M. chimaera, and it may be a general problem for the machine. The researchers found M. chimaera in 18 out of 21 heater-coolers (86%) located at 5 heart surgery departments in Denmark, including the Sorin 3T (14 out of 16 were contaminated) and a Maquet Heater-Cooler (4 out of 5 were contaminated).
Maquet Medical Systems Heater-Cooler
Maquet Medical Systems has warned that its surgical heater-cooler units may be contaminated with bacteria, but said no patient infections have been reported. The company has received a number of reports of contamination with Non-Tuberculosis Mycobacterial (NTM) and other bacteria.
LivaNova Stockert 3T Heater-Cooler
After outbreaks of NTM infections at six hospitals, the FDA warned that evidence “strongly suggests” the LivaNova Stӧckert 3T heater-cooler machines were contaminated at the same source. It may have been at manufacturing facility in Germany where M. chiamara was found in the water and production line in 2014.
FDA Safety Warnings
In October 2015, the FDA published a Safety Communication after heater-cooler devices were linked to 32 reports of infections between January 2010 and August 2015.
In December 2015, the FDA blocked imports of a heater-cooler device made by LivaNova and warned that instructions for sterilization may be inadequate.
In June 2016, the FDA warnined patients that infections from heater-coolers may not cause symptoms for months or years after patients have open-heart surgery involving Stӧckert 3T heater-cooler machines.
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 warned hospitals to “strongly consider” using another heater-cooler device in open-heart surgery. The agency also pointed out evidence that the devices were contaminated at the manufacturing facility in Germany.
List of Outbreaks in United States
Six hospitals in Pennsylvania, Michigan, and Iowa have reported 28 cases of NTM infections associated with heater-coolers since October 2011:
- 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
Legionnaires’ Disease Outbreak Linked to Heater-Coolers
In October 2016, the bacteria that causes Legionnaires’ disease was detected in heater-cooler units at the University of Washington Medical Center in Seattle where 4 patients were infected, including two who died, after having surgery between August 24 and September 13, 2016. This is the first time a heater-cooler unit has been implicated in an outbreak of Legionnaires’ disease. Click here to read more.
What is Non-Tuberculosis Mycobacterium?
Non-Tuberculosis Mycobacterium (NTM) is a type of bacteria that is commonly found in nature, including soil and tap water. It is not contagious and only rarely causes infections in surgical patients with weakened immune system. Unfortunately, the only antibiotics that can kill NTM are also very toxic and have serious side effects.
Symptoms of NTM Infection
Diagnosis is often delayed because NTM is a slow-growing bacteria. It can take months or years before it develops into an infection. The symptoms may include:
- redness, heat, or pus at the surgical site
- muscle pain
- joint pain
- night sweats
- weight loss
- abdominal pain
York Hospital Heater-Cooler Lawsuits
York Hospital in Pennsylvania is facing at least 4 lawsuits from patients who developed NTM infections after a problematic heater-cooler device was used in their open-heart surgery. Click here to read more.
Penn Presbyterian Heater-Cooler Lawsuit
In October 2016, a lawsuit was filed against Penn Presbyterian Medical Center in Philadelphia by a man who developed a severe infection. He blamed the infection on a heater-cooler machine that was used during his aortic valve-replacement surgery at the hospital in 2014. Click here to read more.
Hospitals: Stop Using Tap Water in Heater-Cooler Devices
The CDC recommends that hospitals check heater-cooler devices for NTM contamination and identify any patients who have had NTM-positive tests within four years of cardiac surgery. In addition, hospitals should stop using tap water to rinse, fill, refill or top-off water tanks since this may introduce NTM organisms. Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns.
Do I have a Heater-Cooler Lawsuit?
The Schmidt Firm, PLLC is currently accepting Heater-Cooler induced injury cases in all 50 states. If you or somebody you know has been diagnosed with an infection after heart surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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