Vigilant software produces iso 27001 and gdpr software tools proven to save you time and money in your compliance projects. This drug library is built using the vigilant druglib software. Infusion pump system model z0215, software versions 1. Vigilant druglib orchestra for safer drug settings is a software associated to orchestra base intensive and base primea. Infusion system and vigilant drug library that may cause overinfusion or underinfusion of. Agilia infusion system large volume pump with vigilant drug. Agilia infusion system large volume pump with vigilant drug lib software has the flexible functionality to meet the daytoday needs of multiple care areas within large and small hospital environments. Recalls u of u drug information service university of utah. Aboard software created the first robotic active erp aerp based on stateoftheart artificial intelligence algorithms. Designed to empower nurses and pharmacists with its simplicity, agilia large volume pump with vigilant drug library software is the commonsense choice in smart infusion pumps that helps you put patient safety first. Vigilant drug lib orchestra for safer drug settings is a software associated to orchestra base intensive and base primea. A software program intended to enable a healthcare professional to create, modify and store manage dosage parameters protocols for delivery of medication by an electronic infusion pumps or a syringe pumps which is used in a hospitalinstitution e. Aug 12, 2019 fresenius has also identified four software errors occurring with both the volumat mc agilia infusion system and vigilant drug library that may cause overinfusion or underinfusion of fluidsmedications. It customizes your drug libraries to the needs of clinical care units.
Drug information center highlights of fda activities 8119. 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 081219. This drug library is built using the vigilant drug library software. If a health care provider fails to respond to a kvo, end of. Our active erp suites come with the auto pilot module, an artificial intelligence robotic module that uses the erp functions to actually get the work done. The fda has announced an urgent class i recall of all lots of the fresenius kabi volumat mc agilia infusion pump system model z0215, software versions 1. Care areas a data set containing up to 19 care areas can be created with the vigilant drug library software.
Volumat mc agilia infusion pump and vigilant agilia drug library by fresenius kabi. Aug 12, 2019 the recall is also designed to solve four software anomalies occurring with both the volumat mc agilia infusion system and vigilant drug library that may cause overinfusion or underinfusion of. Volumat mc agilia with vigilant drug library installed. Care areas a data set containing up to 19 care areas can be created with the vigilant druglib software. There have been zero injuries and 14 complaints reported related to these software errors. Reasons for recall of agilia infusion pump and drug library. Volumat mc agilia infusion pump and vigilant agilia. Screening library bioactive screening libraries are readytouse chemical libraries used for drug discovery, lab drug screening, drug target identification, and other pharmaceuticalrelated applications. Fresenius kabi recalls volumat mc agilia infusion pump and. Fda slaps class i label on fresenius kabi usa infusion pump recall. Jan 22, 2020 a software program intended to enable a healthcare professional to create, modify and store manage dosage parameters protocols for delivery of medication by an electronic infusion pumps or a syringe pumps which is used in a hospitalinstitution e. An optional vigilant agilia drug library software may be used to identify dose errors and help reduce them. Vigilant druglib trademark application of fresenius kabi ag. Recall of volumat mc agilia infusion pump and vigilant agilia drug library by fresenius kabi due to alarm and multiple software errors read more education aug 09, 2019.
Agilia infusion system large volume pump with vigilant. Agilia infusion system large volume pump with vigilant druglib. 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. Edwards signaling manufacturers a complete line of audible and visual signals for industrial and commercial applications. Drug library each care area can be defined with one drug library containing up to 200 drugs. Class 1 device recall volumat mc agilia us food and drug. Care areas a data set containing up to 19 care areas can be created with the vigilant drug lib software. Agilia infusion system large volume pump with vigilant druglib software has the flexible functionality to meet the daytoday needs of multiple care areas within large and small hospital environments. Use of these devices may cause serious injuries or death. Fresenius kabi usa is voluntarily recalling the volumat mc agilia volumetric infusion pump and vigilant drug lib to address software anomalies and to upgrade a keep vein open kvo, end of infusion alarm. Registered in england number 05985888 if youre interested in acting as a distributor for our products, please contact us using the contact form. The bioactivity and safety of these drugs were confirmed by clinical trials.
Aug 19, 2019 an optional vigilant agilia drug library software may be used to identify dose errors and help reduce them. This drug library is built using the vigilant drug lib software. Vigilant druglib agilia can upload up to 19 different drug libraries to pumps. Filed in september 9 2015, the vigilant druglib covers computer software exclusively for electronic infusion pumps for medical use, namely, database connection software which defines the safety limits in drug libraries, and uploads drug libraries into infusion pump systems. Resources required to produce and implement a drug library should not be underestimated. Recall infusion pump software alarm priority anomaly, cl i. August 12, 2019 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. Discoveryprobe fdaapproved drug library includes 1971 fda approved drugs for high throughput screening hts and high content screening hcs. In addition, the optional vigilant ders safety software system helps to reduce medication errors and raises the bar for use as a medication management system. Recall infusion infusion pump software anomalies, class i.
Recall infusion infusion pump software anomalies, class. Drug libraries each care area can be defined with one drug library containing up to 200 drugs. The goal is to use this technology for planning and selecting the most appropriate cohorts, using computational methods, before a trial begins. Developing a drug library for smart iv infusion devices. Fresenius kabi usa is voluntarily recalling the volumat mc agilia volumetric infusion pump and vigilant druglib to address software anomalies and to upgrade a keep vein open kvo, end of infusion alarm. Vigilant druglib agilia is a doseerrorreduction software application used to build facilityspecific drug libraries and pump configurations. The optional vigilant agilia drug library is dose error reduction software ders that is installed on a pc platform that communicates with the. Ellipse defibrillators, agilia infusion pumps recalled veterinary. For more information about the agilia large volume pump with vigilant drug library software, please click here. Patients receiving infusions with the volumat mc agilia infusion system with or without the vigilant drug library. Unit 3, clive court bartholomews walk cambridgeshire business park ely, cb7 4ea united kingdom tel. Our free downloads cover various types of employment law topics, such as paid sick leave, overtime laws, pregnancy disability, religious accommodation, marijuana in the. Recalled product volumat mc agilia infusion system and vigilant drug librarymodelsvolumat mc agilia z0215, software versions 1. For complimentary legal guides and model policies for employers, trust vigilant to have the resources you need.
Aug 15, 2019 the fda has announced an urgent class i recall of all lots of the fresenius kabi volumat mc agilia infusion pump system model z0215, software versions 1. Filed in september 9 2015, the vigilant drug lib covers computer software exclusively for electronic infusion pumps for medical use, namely, database connection software which defines the safety limits in drug libraries, and uploads drug libraries into infusion pump systems. Volumat mc agilia infusion systems and vigilant drug library. The alliance between the base intensivebase primea and vigilant drug libraries particularly reduces risks of dose. These software errors could cause serious patient harm or death. Vigilant drug library z073476, software versions 1. Agilia large volume pump the commonsense choice in smart. The recall is also designed to solve four software anomalies occurring with both the volumat mc agilia infusion system and vigilant drug library that may cause overinfusion or underinfusion of. Building on the aforementioned technology, simbiosys plans to create software to virtually test the efficacy of a drug on our library of patients.
Removed exclusions, environmental assessments eas and environmental impact statements eiss. The firm is correcting four software anomalies and kvo keep vein open end of infusion alarm priority in software versions 1. The four software errors occurring with both the volumat mc agilia infusion system and vigilant drug library that may cause overinfusion or underinfusion of fluids. Fresenius kabi usa a company of fresenius kabi ag 2018. Fresenius kabi volumat mc agilia infusion pump and vigilant. The fda has identified this as a class i recall, the most serious type of recall. Aug 21, 2019 vigilant drug lib agilia is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the volumat mc agilia infusion pumps. The recall is also designed to solve four software anomalies occurring with both the volumat mc agilia infusion system and vigilant drug library that may cause overinfusion or. Volumat mc agilia infusion pump recall issued due to risk of. Vigilant also makes mc agilia iv pumps even more intuitive, enabling safer and faster infusion setup. Vigilant druglib agilia fresenius kabi malaysia sdn. It is installed on a computer that communicates with. The food products made from treated animals are safe for people to eat. Vigilant solutions mobile companion is an industryexclusive mobile app delivering the benefits of vigilants intelligenceled policing package including license plate recognition lpr and facial recognition technologies to your mobile device.
Fresenius has also identified four software errors occurring with both the volumat mc agilia infusion system and vigilant drug library that may cause overinfusion or underinfusion of fluidsmedications. Fresenius kabi recalls infusion pump, software massdevice. Vigilant drug library who may be affected health care providers and facilities using a volumat mc agilia infusion system with or without the vigilant drug library. Fresenius kabi recalls volumat mc agilia infusion pump. To inform future library development it might also be useful to collect data across an entire acute trust exploring variation in the delivery of similar infusions and targeting service development accordingly. Fda slaps class i label on fresenius kabi usa infusion pump. Registered in england number 05985888 if youre interested in acting as a distributor for our products, please contact us. This recall is being conducted with the knowledge of the u.
Vigilant druglib software customizes to clinical need create up to 19 care areas, each area. Vigilant drug lib agilia is a software application running on a computer and intended to configure and generate multiple device configurations, drug libraries, care areas and data sets that can then be uploaded to the volumat mc agilia infusion pumps. Our free downloads cover various types of employment law topics, such as paid sick leave, overtime laws, pregnancy disability, religious accommodation, marijuana in the workplace, and more. Braun drug list editor software applications are intended to secure the administration of drugs with configurable drug limits according to clinical practice. Vigilant druglib agilia is the doseerror reduction software ders for agilia iv pumps. Fresenius kabi recalls volumat mc agilia infusion pump, drug. It is installed on a computer that communicates with the pump via usb cable, and can be. Vigilant drug lib agilia can upload up to 19 different drug libraries to pumps. Fda slaps class i label on fresenius kabi usa infusion. The firm initiated the recall by letter on 06242019. Recalled product volumat mc agilia infusion system and vigilant drug library models volumat mc agilia z0215, software versions 1. Drawing on years of experience in developing and deploying risk management tools and services, our product range provides businesses with regulatory software tools that save you both time and money.
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