The Centers for Disease Control and Prevention just sent out a warning to all cardiac surgeons indicating that there is a serious risk of infection in patients who have undergone open heart surgery where the LivaNova Pic heater was used.
Scientists from CDC state that the LivaNova Stockert 3T heater cooler which is frequently used during open heart surgery to maintain the patient’s organs and blood at a specific temperature, may have been contaminated during manufacture. Because of the continuous spread of blood in the body using this machine, experts warn that it can place patients at a risk for life threatening infection.
Any patient who has recently had open heart surgery is asked to seek immediate medical care if they have develop symptoms like muscle aches, fever, night sweats, fatigue, weight loss or generalized malaise.
There are nearly 250,000 open heart surgery bypass procedures done each year in the USA using the LivaNova device, state the CDC. And it appears that some of these patients may be at risk.
The CDC has asked all hospitals that offer open heart surgery to determine which type of cooler-heater system they use in the operating room. The perfusionist who runs the open heart machine during surgery should be very familiar with the make of the heater-cooler device. Any patient who has been on this particular device should be alerted and asked to see his or her healthcare provider.
The agency states that some patients have died after the surgery but it is not yet known what the cause of death is so far.
The other problem is that even if patients have been exposed to bacteria at the time of surgery, the symptoms may be non-specific and may take weeks or months to develop. As a result the diagnosis of the infection may be missed and the treatment delayed.
The device manufacturer has stated that they are working with the CDC to develop a solution to this problem and ensure that surgeons use the device in a safe manner.
Both the US Food and Drug Administration and the CDC initially published this infection warning from the potentially contaminated device a year ago. Initial studies reveal that the device was most likely contaminated with a mycobacterium during the manufacturing process in Germany. A decision to recall the device has not been made as it is a life saving piece of equipment.