Events

Alerte De Sécurité sur INFUSION PUMP COLLEAGUE TRIPLE CHANNEL. Anvisa Registry: 10068390320.

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
    940
  • Date
    2008-09-24
  • 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
    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.
  • Cause
    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