FDA issues safety alert for Baxter Novum IQ large volume pumps
Editor's Note The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus). According to the agency’s July 22…
FDA publishes Baxter update to Novum IQ infusion pump instructions addressing underinfusion risk
Editor's Note Baxter has issued a correction notice for its Novum IQ Large Volume Pump (LVP) after identifying a serious risk of underinfusion linked to the device’s standby mode and power-off conditions. First published on April 24 on the Food and Drug Administration (FDA) website and subsequently reported by Healthcare…
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…
Infusion pump problems prompt early FDA safety warning
Editor's Note Risk of delayed therapy and death related to Ivenix large-volume infusion pumps is prompting supplier Fresenius Kabi USA to pull a subset of the devices from the market, according to an early alert from The US Food and Drug Administration (FDA). Issued December 11, the early alert is…
FDA Class 1 recalls target anesthesia workstations, ambulatory infusion pumps, ventilators
Editor's Note The US Food and Drug Administration (FDA) has designated Class 1 recalls—the most severe category indicating risk of serious injury or death—involving three systems: Atlan anesthesia workstations from Draeger, CADD-Solis ambulatory infusion pumps from Smiths Medical, and Trilogy Evo ventilators from Philips Respironics. FDA issued all three announcements…
FDA designates Class 1 recall for infusion pumps due to air bubble risk
Editor's Note The US Food and Drug Administration (FDA) has deemed Zyno Medical’s recall of Z-800, Z-800F, Z-800W, and Z-800WF infusion pumps a Class 1, the most severe designation indicating serious risk of injury or death. According to FDA’s October 11 announcement, the recall was due to a defect in…
FDA designates Class 1 recalls for infusion pump software, ventilator software
Editor's Note The US Food and Drug Administration (FDA) designated software-related recalls for Fresenius Kabi USA’s Iveni Infusion Systems and Philips Respironics Triology Evo ventilators as class 1, the most severe category indicating serious risk of injury or death. According to FDA’s October 1 announcement, Fresenius recalled the Ivenix Infusion…
FDA designates Class 1 recall for infusion system components
Editor's Note The US Food and Drug Administration (FDA) has designated Fresenius Kabi’s recall of certain Ivenix infusion system components as Class 1, the most severe category indicating risk of serious injury or death. According to the agency’s September 16 announcement, the recalled items consist of a certain lot (3010538)…
Battery problem prompts FDA Class 1 recall for infusion pumps
Editor's Note The US Food and Drug Adminstration (FDA) has classified a recall of ICU Medical’s Plum 360, Plum A+ and Plum A+3 infusion pumps as Class 1, the most severe category indicating risk of serious injury or death. According to he agency’s August 20 announcement, the company is updating…
Study: Intraoperative DEX infusions effectively manage diabetes in cardiac surgery patients
Editor's Note Intraoperative infusion of dexmedetomidine (DEX) could help improve glycemic control and reduce insulin requirements in diabetic patients undergoing cardiac surgery, according to a July 25 article in Medical Dialogues. The article focuses on a prospective observational study published in the journal Annals of Cardiac Anesthesia. The study included…
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