Events

Safety Alert for INFUSION PUMP COLLEAGUE TRIPLE CHANNEL. Anvisa Registry: 10068390320.

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
    940
  • Date
    2008-09-24
  • 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
    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.
  • Reason
    Possibility of saturation of the buffer memory of the equipment / warning about incorrect use of batteries.
  • Action
    Baxter Hospitalar Ltda started on September 15, 2008 a field action with the objective of updating software and part of the hardware of the Colleague Triple Channel infusion pumps. The action applies to all these equipment already marketed in Brazil. For further details on product changes, refer to Appendix 01 - Customer Letter of this alert. In addition, the company has informed UTVIG / ANVISA that NP2-12 batteries not purchased directly from Baxter and / or batteries labeled "Not indicated for medical use" should not be used with Colleague equipment.

Device

INFUSION PUMP COLLEAGUE TRIPLE CHANNEL. Anvisa Registry: 10068390320.

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA