Events

Retiro De Equipo (Recall) de PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Gambro Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00785-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00785-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Gambro has learned of difficulties of disconnection and/or leaks at the level of luer connections on disposable prisma, prismaflex, x-mars and adsorba sets. these conditions may occur when liquid is present on the male or female parts of the luer connector before connection (resulting, for example, from use of disinfectant or drops of priming or dialysate solution) and the wet connector is screwed by using the body of the luer connectors for tightening instead of screwing the coupling nut. under these circumstances, the fluid on the cone can act as a lubricant and might lead to an over-tightening of the connection. the resulting luer connection may be difficult to disconnect and the male luer lock may break when applying a high mechanical force.
  • Acción
    This action has been closed-out on 01/11/2017.

Device

PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
  • Modelo / Serial
    PRISMA, PRISMAFLEX, X-MARS and ADSORBA sets
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd