(Adds details, comments from CDC and company)
By Bill Berkrot
Oct 13 The U.S. Centers for Disease Control and
Prevention on Thursday issued a warning over the risk of serious
bacterial infection to patients who have undergone open-heart
surgery due to possible contamination of a device made by
LivaNova Plc commonly used in the procedures.
The agency said the LivaNova Stöckert 3T heater-cooler
device used to keep a patient's circulating blood and organs at
a specific temperature may have been contaminated during
manufacturing, putting patients at risk of life-threatening
Patients who have had open-heart surgery should seek medical
care if they are experiencing symptoms such as night sweats,
muscle aches, weight loss, fatigue or unexplained fever, CDC
About 60 percent of more than 250,000 heart bypass
procedures in the United States each year use the LivaNova
devices, CDC said.
"Hospitals should check to see which type of heater-coolers
are in use, ensure that they're maintained according to the
latest manufacturer instructions, and alert affected patients
and the clinicians who care for them," Michael Bell, deputy
director of CDC's Healthcare Quality Promotion division, said in
While some patients in this investigation have died, it is
unclear how many were infected and whether infection was a
direct cause of death, the agency said.
Further confounding the problem is the fact that patients
exposed to the bacteria during surgery can develop nonspecific
symptoms that can take months to develop. As a result, diagnosis
of the infections can be missed or delayed, making them more
difficult to treat, CDC said.
"We are working with regulators to develop a solution that
addresses their concerns and ensures continued clinician access
to this important device, which enables lifesaving cardiac
surgery," London-based LivaNova said in a statement.
The CDC and the U.S. Food and Drug Administration initially
published information about the potentially contaminated devices
in 2015. Evidence suggests the bacteria, Mycobacterium chimaera,
contaminated devices during manufacturing in Germany, CDC said.
CDC said it will continue to work with the FDA and clinical
community to further evaluate and reduce risk associated with
these devices, as well as increase provider and patient
While any recall decision would come from the FDA, CDC said
such a move was not feasible, given how often the devices are
"Taking them all out of service at one time wouldn't really
be an option to be able to continue to do those really critical
and life-saving surgeries," a CDC spokeswoman told Reuters.
(Additional reporting by Dipika Jain in Bengaluru; Editing by
Shounak Dasguptat and Cynthia Osterman)