FDA announces recall of Baxter infusion pumps with mismatched software
The U.S. Food and Drug Administration (FDA) has issued an alert on behalf of Baxter, detailing a problem with the company’s Spectrum infusion pumps that could put patients at high risk for serious injury.
Baxter sent a letter to known customers on June 20, urging them to remove the infusion pumps from where they are used or sold. The FDA is relaying that communication as part of its new enhanced medical device recall program, which intends to speed up public notifications for dangerous medical devices.
The Spectrum infusion pumps subject to this recall may have an operational software installed that is incompatible with the pumps themselves, causing them to malfunction. Specifically, software for V6 and V8 model pumps may have been mismatched, possibly leading to underinfusion or overinfusion.
While there have been no reported injuries, given the risks associated with incorrect amounts of fluids or drugs being administered to a patient—including drug overdoses and fluid overload—the recall is being taken very seriously by both Baxter and the FDA, and they are asking supply houses, hospitals and other clinical settings to check inventory to ensure all the potentially defective pumps are isolated and no longer used for patient care.
What is being recalled?
Details on the recalled pumps are below, with all serial numbers linked to the Unique Device Identifiers (UDIs) being impacted by this alert.
Product Description | Product Code | UDI-DI |
Sigma Spectrum Infusion System (V6 Platform) | 35700BAX | 00085412091570 |
Product Description | Product Code | UDI-DI |
Sigma Spectrum Infusion System (V8 Platform) | 35700BAX2 | 00085412498683 |
The FDA included the following images to show where the serial numbers and software codes can be found on the pump’s user interfaces.
Next steps
Anyone who received a letter from Baxter is asked to reply in accordance with instructions. Further, if the notice of this recall was sent by suppliers, providers are also asked to respond to those letters as well.
All pumps in inventory are to be checked to see if they match the UDI on recalled pumps. Software versions should be checked for a match to the model of the pump. If any defective pumps are identified, they should be isolated and returned for a replacement or refund.
For more details, contact Baxter at [email protected] or 800-843-7867.
The FDA and the company are asking that this notice be shared to raise awareness. It can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.