Events

Safety Alert for INFUSION PUMP FOR ENTERAL NUTRITION APPLIX SMART AND APPLIX VISION. Registration at Anvisa: 80145110162.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Fresenius Kabi.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    946
  • Date
    2008-09-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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).
  • Reason
    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