The Centers for Disease Control and Prevention (CDC) is warning heart surgery
patients that a medical device used in their procedures could lead to
a life-threatening infection. A Stöckert 3T heater-cooler device
used in open-heart surgery was potentially contaminated with the rare
bacteria Mycobacterium chimaera during manufacturing.
According to the CDC, more than 250,000 heart bypass procedures using heater-cooler
devices are performed in the United States each year. The 3T heater-cooler
device associated with the infections accounts for 60 percent of the heater-cooler
devices used in the country.
Based on these figures, approximately 600,000 U.S. patients are at risk
for infection with the bacterial species of nontuberculous mycobacterium
(NTM). The agency has confirmed infections in 28 heart surgery patients
in the United States. Across the globe, 12 patients have died. Initial
information suggests that patients who had prosthetic material implanted
are at highest risk for infections.
In October 2015, the FDA issued a
Safety Communication to provide recommendations to minimize patient risk of infections associated
with heater-cooler devices. Subsequent studies have tied the infections
directly to the 3T manufacturing facility. The manufacturer, LivaNova
PLC (formerly Sorin Group Deutschland GmbH), is currently the subject
of several class-action lawsuits.
Because infections are difficult to treat and delays in diagnosis further
complicate patients’ clinical management, the
CDC is warning patients and providers about the risk of infection associated with use of the 3T device. Infections can take months to cause
symptoms, which include night sweats, muscle aches, unexplained weight
loss, fatigue, or unexplained fever.
The CDC is recommending that healthcare facilities immediately evaluate
their heater-cooler units to determine whether they are currently using
— or have previously used — 3T devices. Because the medical
devices can be extremely difficult to disinfect once contaminated with
NTM, the agency warns that hospitals should continue using the device
only if following the manufacturer's most updated sterilization recommendations.
If you or someone you care about has suffered serious harm due to a dangerous
or defective medical device, don’t hesitate to contact
a San Diego product liability lawyer at the Law Offices of Robert Vaage
for a free consultation. Our legal team has successfully represented clients
against manufacturers and distributors of medical devices for more than 30 years.