
Early Alert: Infusion Pump Software Issue from Baxter
The FDA is aware that Baxter has issued a letter to affected customers recommending certain Spectrum Infusion Pumps be removed from where they are used or sold. Baxter has stated that certain Spectrum Infusion Pumps may have an incorrect version of software installed. This could result in a delay or interruption of therapy, underinfusion, or overinfusion.
To date, Baxter has reported no serious injuries or deaths associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Baxter at corporate_product_complaints_round_lake@baxter.com or 1-800-843-7867.
|