INFUSION PUMP COLLEAGUE TRIPLE CHANNEL. Anvisa Registry: 10068390320. 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.

In July 2007 Baxter Healthcare Corporation identified an irregularity related to the saturation condition of the buffer memory of the Colleague Triple Channel infusion pumps, which may cause these devices to interrupt the infusion under certain circumstances. Such irregularities may occur in Triple Channel Colleague equipment using the version (s) of Vista Balance software, Master 5.46 and Slave 4.02. For further information, please refer to the Notice of Technovigilance n ° 888. According to a recent company announcement to UTVIG / ANVISA, the root cause of the problem has been identified and the defects of the software have already been solved by Baxter Healthcare Corporation.