Events

Alerta De Seguridad para AUTOMIX Compounder System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Baxter Healthcare 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
    2012-08-16
  • Fecha de publicación del evento
    2012-08-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120816.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 automix compounder system the united states food and drug administration (fda) has issued a class i recall concerning the following products manufactured by baxter healthcare corporation: automix high speed compounder system (product code 2m8077) automix plus high speed compounder system (product code 2m8075) automix 3+3 compounder system 115v and 230v (product code 2m8286 and 2m8286k) automix 3+3 compounder with accusource monitoring system (product code 2m8287) according to the fda, after fluid ingress into the keypad of the automix compounder's (automix) control module, the automix may generate an incorrect device response to an automix operator's key press. besides, the automix system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. also, the automix system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user. for details, please refer to fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/ enforce_rpt-event-detail.Cfm?action=detail&id=62558&w =08152012& if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 august 2012.

Device

AUTOMIX Compounder System

Manufacturer

Baxter Healthcare Corporation