Events

Safety Alert for COLLEAGUE Volumetric Infusion Pump Mono Channel and Triple Channel. ANVISA Register: 10068390320. Product Codes: 2M8151, 2M8151R, 2M8151RT, BRM8151, BRM8151R, BRM8151RT, 2M8153, 2M8153R, 2M8153RT, BRM8153, BRM8153R, BRM8153RT.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    956
  • Date
    2009-03-09
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Baxter is currently developing solutions for correcting the events reported in this letter. The instructions attached to this letter describe further steps to remedy a discontinuation of therapy if it occurs. The ANVISA Technovigilance Unit is monitoring this case.
  • Reason
    1 ° problem: some error codes shown by colleague infusion pumps can lead to interruption of therapy (infusion), which can lead to complications in critically ill patients, including serious injury or death. 2 ° problem: risks associated with inadequate cleaning procedures. 3 ° problem: occurrence of "out of battery" messages.
  • Action
    The actions recommended to users for each of the reported problems are described in detail in the Letter to Users. Users of COLLEAGUE infusion pumps who do not have a copy of said letter should access it (available at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/956_carta.pdf) and carefully read all instructions, taking the necessary measures to correct / prevent the problems mentioned in this alert.

Device

COLLEAGUE Volumetric Infusion Pump Mono Channel and Triple Channel. ANVISA Register: 10068390320....

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA