3M has recalled more than 165,000 of its Bair Hugger surgical warming blankets due to serious malfunctions that has led to at least one patient experiencing hypothermia.
Air forced through the inflatable blankets helps maintain normal body temperature. An FDA alert said a design change in certain Bair Hugger blankets made airflow blockage more likely. This could prevent the blankets from fully inflating.
“If blankets are only partially inflated during use in surgery, the potential exists for incomplete warming therapy to be given to a patient,” 3M said in a Field Safety Notice sent to health care providers announcing the recall.
More than four in every five U.S. hospitals use Bair Hugger blankets in an estimated 50,000 surgeries every day.
The case on file with the FDA occurred in January 2018 when the surgical patient’s body temperature dropped to 95 degrees. The patient had to be kept under anesthesia longer than planned and required intensive care unit treatment until regaining normal body temperature.
The adverse event report claimed that a defect in the underbody Bair Hugger blanket did not allow proper air circulation around the patient’s legs and one side of the body. The blanket involved was part of one from the lots later recalled.
The affected lot numbers include R10359, R10360, R10361, R10362, R10363, R10364, and R10365. The recalled blankets are only those that fit under the surgical patient. The blankets that are placed on top of the patient are not part of the recall.
3M faces more than 4,200 lawsuits claiming Bair Hugger systems spread infections during surgeries. The company claims the devices are safe and have been used in more than 200 million surgeries.
Four studies published since 2011 have relied on simulations to show that the Bair Hugger system can draw contaminates from operating room air and circulate them into open surgical wounds.
In August 2017, the FDA said it had been unable to identify an association between forced air warming devices like the Bair Hugger and surgical site infections. But the agency promised to continue monitoring the situation.
In recent years, thousands of patients have blamed the devices for serious infections – some resulting in amputations or death.
If you or a loved one have been injured as a result of a Bair Hugger medical device, please contact Attorney Joe Saunders for a free initial consultation.