FDAFDA · Alimentos y medicamentos·N.º oficial Z-2065-2019
Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. 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. Intended patient population: The Vigilant Drug Lib software must only be used to create drug libraries for patients whose weight is 250g to 250 kg (0.6 lbs. to 551 lbs.).
Publicado el 21 de agosto de 2019 · Inicio del retiro: 24 de junio de 2019
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Fenwal Inc
- Distribuidor
- US Nationwide Distribution
- Lote
- All serial numbers distributed in the US
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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