The SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) are software-controlled infusion pumps that deliver controlled amounts of fluids such as pharmaceutical drugs, blood, and blood products and other … See more On December 29, 2024, Baxter sent an Urgent Safety Communication to all affected customers with the following instructions: 1. … See more Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) … See more WebJun 21, 2024 · Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Due to a "Low Priority" "Keep Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Tue Aug 13 …
FDA
WebDec 12, 2024 · Intravenous smart pump drug library compliance: a descriptive study of 44 hospitals. December 12, 2024. Giuliano KK, Su W-T, Degnan DD, et al. J Patient Saf. 2024; 14(4):e76-e82. Although smart pumps can reduce medication errors, user overrides and workarounds prevent safety features from operating as intended. Researchers used … WebDec 2, 2024 · Investigational Drug Service. Medical Services Rep. Dec 02, 2024. Recall of Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) … soy flakes cereal gluten free
Baxter Healthcare Recalls Dose IQ Software Version 9.0.x Because …
WebJul 7, 2024 · for Recall: Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump. FDA Determined Cause 2: Software design: Action: The firm issued an Urgent Medical Device Correction notice by letter on July 7, 2024. WebJan 5, 2024 · Overall, there were more recalls for medical devices and pharmaceuticals in 2024 than there were in 2024. Several litigations involving drugs and medical devices saw spikes in new cases in 2024, … WebImpactful performance. Alerts Workflow gives you high value returns; it increases patient safety, while actually streamlining, expediting, and reducing your workload. Members have experienced great results including: A 50-90% reduction in time spent on alerts/recalls. Often receiving alerts days, weeks, and even months before FDA publication. team pennine facebook