Events

Retiro De Equipo (Recall) de Hemodialysis Monitor

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

¿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-2015-RN-00183-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-19
  • 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-2015-RN-00183-1
  • 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
    This recall is being initiated because of customer complaints indicating the inability to obtain measurements due to the device sometimes seeing no flow or irrelevant flow condition when used with patients during dialysis procedures. no reports of any injuries have been reported nor are expected due to the nature of this issue. the problem is readily identified to the user by a zero or a very low flow value displayed on hd03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
  • Acción
    Emergo is advising their customers to discontinue the use of the monitor and contact Transonic customer service to arrange for replacement (repair/exchange) immediately. This action has been closed-out on 18/07/2016.

Device

Hemodialysis Monitor

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia