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, 621-200ES, 621-300ES, and 621-400ES. 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: 24 de octubre 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. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs, the Door Processor (DP) will not receive the desired input from the user. This issue can be observed in pumps with key panels
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- B Braun Medical, Inc.
- Distribuidor
- Nationwide Distribution.
- Lote
- Multiple serial numbers affected. Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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