On December 1, 2020, the FDA announced Baxter Healthcare is recalling more than a half a million of its Sigma Spectrum Infusion Pumps following reports of unplanned shutdowns that could lead to infusion delays or interruptions in treatment. Unfortunately, there have already been at least 17,493 complaints about the shutdown issue. Even scarier, there have been at least 16 reports of serious injuries associated with the device.
Baxter Healthcare’s Sigma Spectrum Infusion Pumps are portable devices that, when working as intended, reliably deliver blood, blood products, prescription drugs, and other fluids into a patient’s body in a slowed, controlled manner. Infusion pumps are typically used in clinical settings such as hospitals, but may also be found in nursing homes and other assisted-living communities. Baxter Healthcare’s Sigma Spectrum pumps are designed to be set into a patient’s vein or other administration route. Unfortunately, the Baxter pumps at issue have been found to shut down unexpectedly and without warning to patient or caregiver. According to the FDA announcement, these shutdowns may be caused by residue buildup or corrosion on the device resulting from improper cleaning. An unplanned shutdown could interrupt a patient’s treatment, which could be fatal.
Because of the severity of the injuries associated with the unplanned shutdowns, the FDA has identified the recall as a Class I recall, its most serious designation. The expansive recall affects more than 550,000 devices distributed in the United States between 2008 and 2020.
If you or a loved one has suffered serious injuries or died and you suspect this could be attributed to an interruption of the delivery of fluids or medication during an infusion, contact Burg Simpson’s award-winning Cincinnati product liability attorneys today. Our experienced lineup of lawyers has successfully represented thousands of individuals who have been injured by defective products. We are here to help you. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.