Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Baxter Hospitalar Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    956
  • Date
    2009-03-09
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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