Events

Alerte De Sécurité sur Animas 2020, IR1200, IR1250 Infusion Pumps

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Animas Corporation.

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
  • Date
    2012-11-20
  • Date de publication de l'événement
    2012-11-20
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121120.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: animas 2020, ir1200, ir1250 infusion pumps the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a field safety notice concerning animas 2020, animas ir 1200 and animas ir 1250 infusion pumps manufactured by animas corporation. the manufacturer informed the affected users that the software included in these three (animas 2020, ir1250 and ir1200) pump models only operates until midnight on dec. 31, 2015. after this date, these pump models will no longer deliver insulin and will generate call service alarms. this end of use date is not currently included in the product labeling. according to the manufacturer, this software issue will not affect the pumps’ operation prior to january 1, 2016. there is no immediate health risk, and patients using these pump models do not need to take any action at this time. for animas 2020 pump users whose pumps will still be in warranty as of december 31, 2015:- prior to the end of 2015, free replacement pumps to pump users will be provided for those who are still in-warranty to ensure their care with pump therapy is not interrupted. for patients whose pumps are no longer in warranty as of december 31, 2015:- between now and the end of 2015, the manufacturer will be proactively reaching out to all out-of-warranty animas 2020, animas ir1250 and animas ir1200 to remind them of this issue and to ensure their transition to a newer pump model. for details, please refer to the mhra website: http://www.Mhra.Gov.Uk/safetyinformation/ safetywarningsalertsandrecalls/fieldsafetynotices/con205360 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 november 2012.

Device

Animas 2020, IR1200, IR1250 Infusion Pumps
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Animas 2020, IR1200, IR1250 Infusion Pumps
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation