Infusion pumps deemed high-risk in FDA early alert

Editor's Note

Baxter Healthcare Corporation has issued a letter to affected customers recommending certain Spectrum infusion pumps be removed from where they are used or sold, according to a March 5 early alert from the US Food and Drug Administration (FDA).

The FDA notice concerns the Sigma Spectrum Infusion System V6 Platform, recalled due to the potential for missing motor mounting screws after servicing the unit. Affected pumps should be returned for inspection and reservicing. According to FDA, risks to patients include insufficient or excessive therapy, interruption in therapy, or delay in therapy. One serious injury has been reported.