Events

Alerte De Sécurité sur Infusion sets used insulin pumps

Selon National Drugs Administration from El Salvador (DNM), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à El Salvador qui a été fabriqué par Medtronic.

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
  • Classe de risque de l'événement
    Voluntary recall
  • Date
    2017-09-12
  • Pays de l'événement
    El Salvador
  • Source de l'événement
    DNM
  • URL de la source de l'événement
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notes / Alertes
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
  • Notes supplémentaires dans les données
  • Cause
    The cause of the sanitary alert is due to the possible delivery of insulin, which can cause hypoglycaemia and, in extreme cases, death. the sanitary register im101306072017 covers the minimed model. the distributor's facilities were visited and documentation of imports and inventories was requested, the distributor provided a list of lots that are within the alert, as well as instructions from the manufacturer on how to address said alert. so we proceeded to verify and seal the units identified in the alert that were in the warehouse, also, the company said that they had already notified customers to change the product.
  • Action
    - Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

Infusion sets used insulin pumps
  • Modèle / numéro de série
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NDAESDNM