FDAFDA · Alimentos y medicamentos·N.º oficial Z-2175-2013
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
Publicado el 18 de septiembre de 2013 · Inicio del retiro: 5 de diciembre de 2012
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
B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy, or to delivery of an over or under-dose of a therapy if the user was to rely on
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- B Braun Medical, Inc.
- Distribuidor
- Worldwide Disribution: USA (nationwide) and country of: Canada.
- Lote
- Models 620-100 and 620-200; multiple serial numbers
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States