Alerte De Sécurité sur GEMSTAR INFUSION PUMP / Model: 7 THERAPIES / ANVISA Registry # 80253310025.

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 Hospira Costa Rica Ltd..

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
  • Date
  • Pays de l'événement
  • Source de l'événement
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Company Field Action Code: FA302-01. The severity of the delay or discontinuation of therapy depends on the underlying condition of the patient and the prescribed treatment. A delay / interruption in therapy may, in the worst case, result in a serious adverse event. Lithium batteries older than 3 years must be replaced. Health professionals are advised to evaluate the risks / benefits to patients associated with the use of the equipment when administering critical therapies. Clients should contact a Hospira representative for the use of an alternate pump, particularly for patients in whom delayed / discontinued therapy can lead to serious injury or serious adverse events. For customers who periodically check the historical records of Gemstar infusion pumps, it is suggested that it be performed more frequently to reduce the amount of information in the registry that could be lost if this failure occurs. Instructions for downloading the files can be found in the Gemstar System Operation Manual. Access the letter to the clients, see the link: #### UPDATED IN 23 / 08/2017, the field action documentations sent by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Cause
    An internal, non-user lithium battery is used to power the memory that stores current infusion settings and event history records when the pump is turned off. if the battery voltage level falls below 2.4 volts, an 11/004 error will be displayed and the infusion pump can not be used, resulting in possible delay / interruption in therapy. in addition, the infusion settings and event history records will be cleared.
  • Action
    Replacement of lithium batteries older than 3 years.


  • Société-mère du fabricant (2017)
  • Source