Events

Alerte De Sécurité sur INFUSION PUMP FOR ENTERAL NUTRITION APPLIX SMART AND APPLIX VISION. Registration at Anvisa: 80145110162.

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 Kabi.

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
    946
  • Date
    2008-09-03
  • 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
    According to information from the company that owns the registry in Brazil, the pump has in its software functions to detect situations of occlusion of the equipment. These functions have been developed and improved since its first release. There are three versions in the following order: Version 1 (from the initial version): a function is implemented that detects downstream occlusions; Version 2 (as of May 2006, serial number 199503812): An upstream occlusion detection has been added to detect occlusions resulting from improper installations upstream of the pump (eg folded or compressed equipment, juxtaposition of the equipment or agglomeration of food, among others). This function requires a small volume to be provided to test the system's (pump and nutrition equipment) status. This volume (4ml) is supplied within the first 30 seconds after the start of pump operation. Version 3 (as of July 2007, serial number 19923272): An improved upstream occlusion detection algorithm has been implemented that allows a reduced initial volume (2ml) for low flow rates (below 50ml / h) and one volume compensation within the first hour (see details in the Instructions for Use). For more details, consult the Letter to Customers sent by the company that owns the product registration in Brazil (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/946_carta_clientes.pdf).
  • Cause
    According to information from the company holding the register, the factory unit, fresenis kabi deutschland gmbh, received two reports of digestive disorders suffered by newborns, which were induced by the initial volume generated at the initialization of the equipment due to the automatic function of occlusion detection not computer.
  • Action
    The company informs the following actions: 1. Send letter with the relevant guidelines to evaluate the equipment to customers. 2. Add in the Instructions for Use the item "Important Remarks", an explicit illustration which demonstrates the identification of the software and the initial volume of nutrition. 3. Request in the Anvisa to change the legal information of Use Instructions / Equipment User Manual.

Device

INFUSION PUMP FOR ENTERAL NUTRITION APPLIX SMART AND APPLIX VISION. Registration at Anvisa: 80145...

Manufacturer

Fresenius Kabi