Events

Alerta De Seguridad para Animas 2020 Insulin Infusion Pump

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Animas Corporation.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-02-05
  • Fecha de publicación del evento
    2013-02-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130205.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Animas 2020 Insulin Infusion Pump
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation