Alerta De Seguridad para VOLUMETRIC PUMP OF INFUSION COLLEAGUE.

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.

This field action is not related to recall or change of any equipment - it is an update of the instructions for use of the product. According to Baxter, a lack of important information was identified in Chapter 4 of the Instructions for Use of the current version of the Operator's Manual (Instruction of Operation: Secondary Infusions) of the Colleague pump product codes. The Operations Manual currently instructs the user to close the lock (if one above the pump) in the primary setting before initiating the secondary infusion, and once the secondary infusion is completed, the pump automatically reverts to the primary rate or to a rate KVO if a primary infusion is not scheduled. However, the Operator's Manual does not instruct the user to reopen the setting lock (if one above the pump) in the primary setting after the secondary infusion has been completed, otherwise it may result in delayed infusion.