FDAFDA · Alimentos y medicamentos·N.º oficial Z-2113-2018
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.
Publicado el 13 de junio de 2018 · Inicio del retiro: 8 de mayo de 2018
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 will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Baxter Healthcare Corporation
- Distribuidor
- Worldwide Distribution - US Nationwide and the country of Canada.
- Lote
- All serial numbers manufactured from7/1/2014 and forward, with release dates 7/1/2014 and forward.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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