Events

Alerte De Sécurité sur COLLEAGUE volumetric infusion pump, ANVISA registration number 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
    836
  • Date
    2006-07-31
  • 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 Hospitalar Ltda has already begun corrections and updates of the COLLEAGUE infusion pumps in the country with an expected end in July 2007. The company also informs that there were no registered deaths in Brazil related to the equipment. Inquiries regarding COLLEAGUE pumps, please contact Customer Service at 0800 12 55 22, option 3. The Technological Surveillance Unit - UTVIG / NUVIG / ANVISA is following the actions of the company.
  • Cause
    Baxter healthcare corporation is providing a "global update" of colleague infusion pumps.
  • Action
    Baxter Hospitalar Ltda informs that the "global update" corresponds to: 1. Replacing the User Interface Module printed on the circuit board to solve the Y2A crystal circuit event; 2. Install from a new version of the software to obtain the following: a. Limit the battery discharge after 3 minutes in the dead battery alarm status. B. Increase visual indicators and battery messages to allow a better understanding of current battery charge levels. w. Include a confirmation window that will appear when the user attempts to turn off the pump. d. Troubleshoot external communications port errors. 3. Replace battery wiring to the extent necessary to reduce the possibility of battery deformation. New batteries will be installed in the pumps as part of this action; 4. Modify the upper jaw of the pump pumping channel to reduce the possibility of insufficient infusion; 5. Perform a review of all pumps to ensure that all previous modifications have been made; 6. Provide with each pump a corrected Operator's Manual reflecting all the updates performed and where the instructions are clarified.

Device

COLLEAGUE volumetric infusion pump, ANVISA registration number 10068390320.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA