LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Publicado el 20 de marzo de 2024 · Inicio del retiro: 10 de mayo de 2023
Estado reportado al momento de publicación: Completed — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
Qué hacer
Voluntary: Firm initiated · Other
Detalles del retiro
- Fabricante
- Fresenius Kabi USA, LLC
- Distribuidor
- US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
- Lote
- UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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