Alerta De Seguridad para Enteral Nutrition Equipment for use with Macrogotas Infusion Pump, Hazard Class II, Brand: Baxter, Registro: 80145240369 .. Serial Numbers: SEE ANNEX - DISTRIBUTION LIST

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 described in the Instructions for Use of the Colleague Pump, they are able to infuse medications, solutions, parenteral nutrition, lipids, blood and blood components. It is important to note that, according to the manufacturer, the Colleague Infusion Pump is NOT designed for enteral administration (SEE CUSTOMER LETTER). /// According to the manufacturer's information there is no risk to patients of injuries. A failure in the amount of solution administered may occur due to flow failure during administration. In this case the patient may present with adverse symptoms such as abdominal distension, diarrhea and hyperperistalse.