The removal is tied to incorrect software installations that could result in inaccurate flow rates and user confusion during clinical use.
Baxter is removing Sigma Spectrum Infusion System Platforms after finding certain Spectrum infusion pumps may have an incorrect version of software, according to a US Food and Drug Administration (FDA) recall notice.Â
According to the notice, a software version intended for Spectrum V8 may have been installed on the affected Spectrum V6 pumps, and a software version intended for Spectrum V6 may have been installed on the affected Spectrum V8 pumps. Spectrum software is designed for the pumping mechanism setup specific to each pump platform. The V8 software installed in a Spectrum V6 pump, or vice versa, may cause an inaccurate flow rate of overinfusion or underinfusion, especially over a long run time.Â
Additionally, the V6 and V8 designs include many differences in the clinical workflow and user interface. The appearance of the menus and the requested inputs from the pump are different between the two platforms. If a user who was trained and experienced on a V6 pump was presented with a V6 pump with V8 software, or vice versa, they may experience confusion and delay during use or may accidentally mis-program the infusion.
This could result in a delay or interruption of therapy, underinfusion, or overinfusion. The issues described above may lead to serious adverse health consequences such as drug toxicity, overdose, fluid overload, electrolyte imbalances, and delayed or subtherapeutic drug levels causing ineffective treatments. The severity and nature of these outcomes include serious injury and death, and are dependent on the type of medication, fluid, or infusate being delivered and the clinical condition of the patient, with high-risk populations being particularly vulnerable.
Spectrum infusion pumps are intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified health care professional.
Affected products:
| Product Description | Product Code | UDI-DI |
| Sigma Spectrum Infusion System (V6 Platform) Affected Serial Numbers | 35700BAX | 00085412091570 |
| Product Description | Product Code | UDI-DI |
| Sigma Spectrum Infusion System (V8 Platform) Affected Serial Numbers | 35700BAX2 | 00085412498683 |
The FDA has identified this recall as Class I, the most serious type. This device may cause serious injury or death if you continue to use it. The FDA notes that it is aware Baxter has issued a letter to affected customers recommending certain Spectrum Infusion Pumps be removed from where they are used or sold.Â
Customers in the US with adverse reactions, quality problems, or questions about this recall should contact Baxter at [email protected] or 800-843-7867, according to the FDA.
