Alerta De Seguridad para Equipment for paclitaxel with air intake, model AMC9627, hazard class II, Brand name: Baxter, Record number: 10068390316. Number of lots: 14H04V366, 14I01T752 and 14K28T473.

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.

Baxter informs that this kind of leak can be easily detected during the priming of the equipment or in the initial set up that is performed with a solution, even without the drug. However, if not checked immediately, the leak could have adverse consequences to the patient's health by generating a break in the sterility of the fluid pathway with subsequent contamination of the solution, which was considered serious and would potentially require medical intervention; or by possible contact of the solution with the skin, which could cause irritation. Since this type of leak is easily detected, the risk of medically reversible or transient damage in the general population is considered remote and in a high-risk population of fatal adverse events is also considered remote.