The Food and Drug Administration (FDA) has ordered a medical device manufacturer to recall and destroy some 200,000 infusion pumps currently in use in hospitals and health care clinics to accurately deliver fluids, such as nutrients and medications, into a patient’s body. According to the May 3, 2010, notice, the agency has been working with the manufacturer since 1999 “to correct numerous device flaws,” which have included battery swelling, inadvertent power off and service data errors. The agency has received more than 56,000 adverse event reports associated with the device and claims these events “have included serious injuries and more than 500 deaths.”
The company apparently most recently submitted to the FDA a correction schedule that “did not plan to begin the latest round of corrections to the adulterated and misbranded pumps until May 2012.” In addition to the recall and destruction, FDA has ordered the company to reimburse customers and assist them in finding a replacement device. FDA will hold a public workshop in May 2010 on infusion pump design, noting that the problems this manufacturer has experienced are not unique. See FDA News Release, May 3, 2010.