Events

Alerte De Sécurité sur Animas 2020 Insulin Infusion Pump

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
    2013-02-05
  • Date de publication de l'événement
    2013-02-05
  • 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_20130205.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 insulin infusion pump health canada has posted a medical device safety alert concerning animas 2020 insulin infusion pump manufactured by animas corporation. the affected model/catalogue numbers are 100-380-51, 100-381-51, 100-382-51, 100-384-51, 100-385-51 respectively. a small number of animas 2020 insulin infusion pumps are potentially affected by a misalignment of a component on the printed circuit board assembly. this component misalignment results in the insulin pump potentially measuring force conditions incorrectly, resulting in false warnings and/or alarms. should the patient complete a load sequence or prime the insulin infusion pump and does not disconnect from the infusion set from the body, the insulin infusion pump may dispense all of the insulin in the cartridge into the patient. there is no safety risk as long as the patient follows the instructions for use and always disconnects the infusion set prior to priming the pump, changing the cartridge, and rewinding the motor. according to the local supplier, the affected products are not distributed in hong kong. for details, please visit the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/ rec-ret_md-im_date_jan-mar_2013-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 05 february 2013.

Device

Animas 2020 Insulin Infusion Pump
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Animas 2020 Insulin Infusion Pump
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation