WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) said recently that the agency labeled the Becton Dickinson (BD) Alaris infusion pump system recall as Class I. A Class I recall, as defined by the FDA, means that a medical device or medication could cause serious injury or death if the device or medication if patients continued to use the recalled item. According to Med Tech Drive, BD’s pump infusion system, recalled dye to system errors and software problems, has led to one death and 55 injuries. BD said that 774,000 of its recalled devices are in use in the United States alone. The FDA and BD reached an agreement on a plan to remediate the problem.
The devices and modules subject to the recall are vulnerable to many computer-based errors. The errors users might encounter are software or system errors, a delay in programming options, low battery alarm failures, malfunction of alarm priorities between settings, and custom programming errors. Any one of these critical errors could result in the death of the patient or cause a serious injury.
The FDA indicated that BD mailed instructions to its customers, outlining the problems and offering solutions. BD called its’ customers attention to the impending software update and cautioned users that without the necessary software update, the system errors and software errors could occur. Also, BD sent instructions to users to help them mitigate the possible occurrence of errors in the machine.
BD claims that its Alaris Pump Injection system is entirely safe to use once the company updates the software that runs the device. Despite BD’s strong stance behind its products, the FDA has ordered the company to repair its devices, which are typically used in neonatal and pediatric care but can also be used on adult patients.
BD did not provide a timeframe when the firm would rollout the software upgrade.
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