Alerte De Sécurité sur VOLUMETRIC PUMP OF INFUSION COLLEAGUE.

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; Baxter Healthcare.

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
    1325
  • Date
    2013-11-08
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    This field action is not related to recall or change of any equipment - it is an update of the instructions for use of the product. According to Baxter, a lack of important information was identified in Chapter 4 of the Instructions for Use of the current version of the Operator's Manual (Instruction of Operation: Secondary Infusions) of the Colleague pump product codes. The Operations Manual currently instructs the user to close the lock (if one above the pump) in the primary setting before initiating the secondary infusion, and once the secondary infusion is completed, the pump automatically reverts to the primary rate or to a rate KVO if a primary infusion is not scheduled. However, the Operator's Manual does not instruct the user to reopen the setting lock (if one above the pump) in the primary setting after the secondary infusion has been completed, otherwise it may result in delayed infusion.
  • Cause
    Operator's manual does not instruct the user to reopen the setting lock in the primary setting after the secondary infusion is completed and the pump reverts to primary infusion.
  • Action
    Correction of information in the Operator's Manual.

Manufacturer