The FDA announced today that the recall of the Clearlink basic solution set with Duovent from Baxter (NYSE:BAX) is Class I, the most serious kind. Clearkink with Duovent is part of a system for administering drugs and solutions to patients. Health providers use the majority of the sets to deliver hazardous drugs, such as chemotherapy […]
Baxter
CISA warns on cybersecurity vulnerabilities for certain Baxter infusion pumps
The U.S. Cybersecurity and Infrastructure Security Agency (CISA) today issued a warning on some Baxter (NYSE:BAX) infusion pumps. Sigma and Baxter Spectrum infusion pumps are included in a CISA notice over remotely exploitable vulnerabilities. Those vulnerabilities include: missing description of sensitive data, use of externally controlled format string and missing authentication for critical functions. The […]
FDA clears syringe infusion pump with Dose IQ software from Baxter
Baxter (NYSE:BAX) announced today that the FDA issued 510(k) clearance to its Novum IQ infusion pump with Dose IQ safety software. Deerfield, Illinois-based Baxter designed its new Novum IQ syringe infusion pump (SYR) to deliver small amounts of fluid at low rates. It includes a technologically integrated user experience with enhanced safety features. The system […]
BD wins patent fight against Baxter over drug-transfer system
BD (NYSE:BD) picked up a legal victory in a patent spat with Baxter (NYSE:BAX) over a system for moving drugs. A federal judge in Chicago ruled that BD’s PhaSeal system for transporting hazardous drugs between syringes and vials doesn’t infringe two patents belonging to Baxter. U.S. District Judge Joan Lefkow granted BD summary judgment on […]
Baxter warns of alarm malfunction on some infusion pumps
Baxter (NYSE:BAX) announced today that it has issued an urgent safety communication regarding upstream occlusion alarms for certain infusion pumps. Deerfield, Illinois–based Baxter warned that incorrect administration set setup and/or the incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication. The problem might occur without the users receiving alerts […]
Baxter touts data supporting use of machine learning for infusion pump programming
Baxter (NYSE:BAX) announced today that data shows the potential for machine learning supporting decision-making with infusion pump programming. Deerfield, Illinois-based Baxter presented the data from a retrospective study — part of a collaboration with MedAware aimed to develop next-generation dose error reduction software — at the American Society of Health-System Pharmacists (ASHP) 2021 Midyear Clinical […]
Baxter bolsters fill-finish capabilities with $100M investment in Germany
Baxter International (NYSE:BAX) plans to invest roughly $100 million to expand a sterile fill-finish manufacturing plant in Halle/Westfalen, Germany. BioPharma Solutions (BPS), a subsidiary of Deerfield, Illinois–based Baxter, will manage the new facility. BPS supports pharmaceutical companies through a range of offerings, including scientific support, sterile contract manufacturing and parenteral delivery systems. Get the full […]
FDA approves Baxter’s norepinephrine injection for treating low blood pressure
Baxter (NYSE:BAX) announced today that it received FDA approval for its premix norepinephrine bitartrate in 5% dextrose injection. Deerfield, Illinois-based Baxter launched the norepinephrine injection following the approval for raising blood pressure in adult patients with severe, acute hypotension (low blood pressure). According to a news release, the company’s formulation of norepinephrine is the first […]
Baxter working on software upgrade for serious Spectrum IQ problems
Baxter (NYSE:BAX) this week issued an urgent medical device correction for all of its Spectrum IQ infusion pumps. Earlier this month, FDA designated a recall of Baxter’s Dose IQ safety software program as Class I, its most serious level. Baxter designed the Dose IQ as a standalone computer-based software program that allows care providers to […]
Baxter has a serious recall involving infusion pump software
The FDA issued a Class I recall — the most serious kind of recall — for Baxter’s Dose IQ safety software program. Baxter designed its Dose IQ safety software as a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications, which are delivered into […]
