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Drug library software recalls

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 …

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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 https://aulasprofgarciacepam.com

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

Drug Recall Monitoring and Trend Analysis: A Multidimensional …

Category:Class 2 Device Recall Baxter SIGMA Spectrum Infusion Pump …

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Drug library software recalls

Lupin Blood Pressure Medication Recall - Health

WebJan 5, 2024 · BD Alaris issued recalls for more than a million infusion pumps and pump modules in 2024 for software and hardware problems. Hospitals and health care facilities use the infusion pumps to deliver … WebMCE FDA-Approved Drug Library is a good tool for drug repurposing which could dramatically accelerate drug development. MCE FDA-Approved Drug Library can be supplied as pre-dissolved Solutions or …

Drug library software recalls

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WebJul 25, 2012 · Company:Sigma Date of Enforcement Report 7/25/12 Class lll: PRODUCT SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: WebApr 14, 2024 · bypassing the smart infusion pump or the drug library accounted for about 10% of the total number of errors or policy violations relating to infusion …

WebAug 13, 2024 · The recall occurred due to a software defect that may lead to mismatched drug information in drug libraries created using version 9.0.x of the computer-based …

WebMar 2, 2015 · Recall Status 1: Terminated 3 on May 22, 2024: Recall Number: Z-1451-2015: Recall Event ID: 70658: 510(K)Number: K133801 Product Classification: Pump, … WebAug 9, 2024 · Summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.

WebAug 18, 2024 · Recall Number: Z-2165-2024. REASON. 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. RECALLING FIRM/MANUFACTURER. Baxter Healthcare Corporation on 7/7/2024. Voluntary: Firm …

WebMar 28, 2024 · The United States Food and Drug Administration (FDA) is providing a continuous and comprehensive updated list for various healthcare issues including drug recalls. Methods: This study provides a multidimensional analysis using statistical process control (SPC) tools to evaluate the risk associated over a 3-year period (2016–2024). team pennine halifaxWebAug 10, 2024 · We identified a total of 250 recall events between 2010 and 2016, with 165 eligible for analysis. Linear accelerators (LINACs) (28%) and LINAC control software (19%) were the most frequently recalled products. The most common FDA-determined causes for recalls were software design (42%) and device design (26%). team pennine hx5 9hdWebFeb 12, 2024 · Contact the FDA. You can contact the FDA’s Center for Drug Evaluation and Research (CDER) with any questions or concerns at [email protected] or through … soy footprint of animal products in europeWebDrug recalls are actions taken by a firm to remove a product from the market and may be conducted on a firm's own initiative, by FDA request, or by FDA order under … soy foods isoflavones and breast cancerWebOur OneRecall Product Management web app provides on-demand access to current and historical recall information, so you can easily manage a recall and generate standardized reports for regulatory agencies. Flexible reporting meets your unique needs, and includes: Visibility to item disposition. Product information by NDC and lot number. team pennant templateWebThe 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. Recalled Products • Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) o Product Code: 35700ABB and 35700BAX • Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) soy foods and breast cancerWebMar 17, 2024 · The Food and Drug Administration (FDA) enforces standards for prescription medications, medical devices, and vaccines through the recall process. This process ensures that drugs and other medical products are safe and efficacious. Pharmacists can optimize healthcare outcomes by staying up-to-date on FDA recalls, sharing information … team pelfrey