INFUSION PUMP FOR ENTERAL NUTRITION APPLIX SMART AND APPLIX VISION. Registration at Anvisa: 80145110162. 의 안전성 경고

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.

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).