Baxter Recalls Spectrum Infusion Pumps

Baxter Healthcare is recalling its Sigma Spectrum Infusion Pumps with Master Drug Library (V6, V8) and the Baxter Spectrum IQ Infusion Systems with Dose IQ Safety Software (V9) because improper cleaning may lead to residue build-up or corrosion on the device. “If the device is running only on battery power, this may lead to an unplanned shutdown without alarming or alerting the user,” a recall notice says, adding that it may cause an infusion delay or an interruption in treatment. Such problems may cause serious adverse events, including death, it says. To date, there have been 17,493 complaints about the issue and 16 reports of serious injuries.

The infusion pumps are software-controlled to deliver controlled amounts of fluids (drugs, blood, and blood products and other required patient therapies). The fluids are provided through an infusion tubing set into a patient’s vein or through other cleared administration routes.