The US Food and Drug Administration (FDA) has tagged the recall of software used in Becton, Dickinson and Company’s (BD) infusion pumps as Class I.
Although there have been no injuries or deaths reported due to the software issues, Class I indicates that continued use of the recalled products, without actions being taken, could cause serious injury or death. Class I is the most serious designation for a recall issued by the FDA.
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Shares in the NYSE-listed company opened 0.3% down on 21 March following the FDA notice the day before. The company has a market cap of just under $66bn. BD’s stock price has been under the spotlight after announcing plans last month to separate its biosciences and diagnostics business from the rest of the organisation.
The recall impacts the BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter. These are independent pieces of software that help connect the company’s infusion pump, Alaris, to computers and a hospital’s electronic medical record systems. The pump is used for the administration of ongoing or repeat doses of fluids such as medication, red blood cells, or other blood products to patients.
An issue with software, as reported by customers, means there are delayed system responses and backlogging of automated programming requests (APRs). This means that the Alaris computer may receive outdated APRs, resulting in patients receiving inaccurate therapy. A different administration rate, dose, or volume parameters could mean over or under-infusion of a particular fluid.
Under investigation
The FDA stated that the use of the pump with the faulty software can lead to complications caused by sudden pump stopping, or that over or under-infusion could lead to death. According to the agency’s recall database, the cause is still “under investigation by the firm”.
Earlier this month, BD and its CareFusion subsidiary, which provides the products, sent customers a letter recommending corrective actions. These included reviewing parameters before starting therapy, making staff aware of the issue, and letting the BD know whether there is an affected product on-site.
The global infusion pump market was estimated to be worth $2.6bn in 2023 and is forecast to grow to $3.3bn by 2033. BD is listed as having the third largest market share in North America, as per GlobalData analysis.
The company is far from the only manufacturer experiencing infusion pump woes due to problematic software. Baxter recalled nearly 23,000 of its devices in August 2023 due to software issues – the FDA also tagged this event as Class I. In addition, OptumHealth also underwent a Class I recall in May 2024 related to 208 pumps that were affected by software failure modes while Smiths Medical issued a medical device correction for its software-affected infusion pumps in August 2024.
