Events

Alerta De Seguridad para PUMP FOR INFUSION OF ENTERAL NUTRITION - MOD. APPLIX SMART and APLLIX VISION.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Fresenius Vial.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    910
  • Fecha
    2008-04-17
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    The company Fresenius Kabi Brasil Ltda informed in a letter of communication sent to the Anvisa's Unit of Technovigilance that it will be sending letters of communication to clarify to its clients about the correct positioning of the equipment in the infusion pumps for enteral feeding. The company also informed that it will be providing to GQUIP / ANVISA (Equipment Technology Management) to change the legal information of use instructions contained in the Product Use Manual.
  • Causa
    If the equipment is improperly adjusted in the pump, there is a risk of free flow of fluid and consequent overdosage of enteral nutrition.
  • Acción
    UTVIG / ANVISA recommends that persons responsible for the use of pumps: (1) Identify the products listed in their inventory; (2) Check whether all those directly involved in the operation of the infusion pumps (doctors, nurses, patient's relatives, etc.) are adequately trained; (3) Ensure that the instructions contained in the user manual are available and easily accessible to the pump operators; (4) Ensure that pump operators are performing visual inspection of these equipment and recording any observed nonconformities; (5) Ensure that pump operators are following the manufacturer's instructions for installation of the equipment (see Annex 01).

Device

PUMP FOR INFUSION OF ENTERAL NUTRITION - MOD. APPLIX SMART and APLLIX VISION.

Manufacturer

Fresenius Vial