January 19, 2017 — A new study suggests that nearly all open-heart surgery patients in the last decade were exposed to a dangerous bacteria from heater-cooler machines.
Most heater-coolers made in the last 8-10 years were contaminated with M. chimaera, a slow-growing bacteria that causes NTM infections. It may be a general problem for the machine.
Last year, FDA issued a Safety Communication and said the evidence “strongly suggests” a single source of contamination with the NTM bacteria M. chimaera.
Contamination of heater-coolers may be extremely widespread, according to a new study published ahead of the March 2017 print edition in the journal Emerging Infectious Diseases
Researchers collected M. chimaera in 18 out of 21 (86%) heater-cooler units from 5 heart surgery departments in Denmark, including the Sorin 3T (14 out of 16 were contaminated) and a Maquet (4 out of 5 were contaminated) and analyzed the DNA of the bacteria.
NTM bacteria in the Sorin 3T were “nearly identical” to each other, but genetically distinct from NTM bacteria in the Maquet heater-coolers.
Unexpectedly, NTM bacteria in the Denmark Sorin 3T heater-coolers were “nearly identical” to those found in the United States and United Kingdom, and similar to all Sorin 3T-associated patient infections. The researchers concluded:
“We find it likely that most Sorin 3T HCUs made in the past 8–10 years potentially are contaminated by the same M. chimaera strain. In addition, because 80% of the Maquet HCUs also contained M. chimaera … we suggest mycobacterial contamination might be a general problem for HCUs.”
The Sorin 3T Heater-Cooler System is used at 60% of hospitals that perform open-heart surgery (also known as cardiopulmonary bypass). The system control the blood temperature of patients during surgery.
Water in the system never directly touches the patient, but a fan on the back of the machine can blow evaporated water — and bacteria in the water — into the air of the operating room and onto a patient.
Non-Tuberculosis Mycobacteria (NTM) is a slow-growing bacteria that is common in soil and water. If it gets inside a patient’s body, it can cause deadly infections, but symptoms may not appear for 5 years.
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 a Nontuberculosis Mycobacteria (NTM) infection, 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.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.