Alerta De Seguridad para Continuum Infusion System Compatible with RM Medrad. Anvisa Registry n ° 80172890013.

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.

In April 2012 a deviation in the accuracy of some equipment from the Continuum Infusion Compatible with RM Medrad system was reported by Anvisa through Technovigilance Alert No. 1133. There was voluntary recall of equipment by MEDRAD due to variations in the material of the tubes used in the manufacture of disposable infusion sets. Such variations resulted in performance drift in flow accuracy when in use in conjunction with Continuum infusion pumps. In view of the problems encountered, the company decided to completely withdraw from the market, until June 2015, the Continuum Compatible Infusion System with Medrad RM.