Alerta De Seguridad para Colleague Volumetric Infusion Pump. Registration Anvisa n ° 10068390320 .. Models: Colleague, Colleague 3, Colleague CXE and Colleague CXE 3.

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.

As a result of an evaluation carried out by the company on complaints received between 2011 and 2013 involving the product, it was observed that a significant number of notifications reported that the equipment did not care; after evaluation of the data, the root cause was attributed to an error of use due to non-release of the manual tube from the equipment tube. The Colleague Infusion Pump Operator's Manual tells you which procedure to follow when Manual Tube Release (LMT) is used. Check for additional information in the Baxter Alert Message, available at: LINK - AWAITING PUBLICATION.