Events

Alerte De Sécurité sur PUMP FOR INFUSION OF ENTERAL NUTRITION - MOD. APPLIX SMART and APLLIX VISION.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Fresenius Vial.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    910
  • Date
    2008-04-17
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    If the equipment is improperly adjusted in the pump, there is a risk of free flow of fluid and consequent overdosage of enteral nutrition.
  • Action
    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