Events

Alerta De Seguridad para Artis Dialysis System

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

¿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
    2017-03-06
  • Fecha de publicación del evento
    2017-03-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170306a.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: baxter healthcare artis dialysis system medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its artis dialysis system [product code: 110635 (artis 230v), 115323 (artis 230v physio, and 115962 (artis 230v physio i); software version: 8.09, 8.15, 8.33 and 8.52]. the manufacturer is initiating a field action to update the software version for the above models and software version of artis dialysis system in hong kong. the current version allows for the possibility of resetting and continuing patient treatment without following the instructions for addressing alarm #642, “arterial chamber: level adjustment required.” this will subsequently deactivate the alarm for the remaining treatment time. the reset that follows will predispose patient to venous air embolism. the new software versions prevent the possibility of continuing the treatment without following the instructions for addressing alarm #642, as written in the operator’s manual. deactivation of the alarm #642 for the remaining treatment time following a reset will predispose patient to venous air embolism. there were no adverse events and complaints reported in hong kong that potentially related to this issue. operator may continue to safely use the affected artis dialysis systems while utilizing additional vigilance to adhere to the instructions for use for addressing alarm #642, as documented in the operator’s manual until the software upgrade is completed. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 march 2017.

Device

Artis Dialysis System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter Healthcare Artis Dialysis System
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare