The Franklin Lakes, N.J.–based company has had shipments of the pumps on hold since early this year, when FDA called for a comprehensive 510(k) submission to covers a host of software fixes needed after a Class I-level recall. Pumps are only going to health providers with an immediate medical need.
The company expects to submit the 510(k) in late Q2 or early Q3 (around spring 2021), CEO Thomas Polen said during a Nov. 5 earnings call.
Alaris problems have been a major challenge for BD, which is also grappling with the COVID-19 pandemic. In the quarter ended Sept. 30, the Alaris ship hold affected revenue by 240 basis points, Polen said on Nov. 5.
“The highest priority of the organization continues to be preparing for a comprehensive 510(k) filing obtaining clearance for Alaris and returning our market-leading infusion pump franchise to growth,” Polen said. “Over the last quarter, the team has made further progress and retired risk.”
Warnings meanwhile continue to go out about the pumps. The company last week warned about cybersecurity issues; the notice applied to BD’s Alaris PC unit, model 8015, versions 9.33.1 and earlier, as well as the Alaris systems manager, versions 4.33 and earlier.
A Field Safety Notice from BD, posted Nov. 13 in Germany, involved the Alaris GW and GW800 volumetric pumps and that BD is updating directions for ise to include additional warnings related to the use of non-dedicated/noncompatible administration sets to mitigate against unregulated flow during infusion.