Events

Retiro De Equipo (Recall) de Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulmonary bypass)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Terumo Australia 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-2016-RN-00125-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-10
  • 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-2016-RN-00125-1
  • 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
    Terumo cardiovascular systems (terumo cvs) has received complaints of the cdi system 500 monitor displaying the “h/s disconnect at cuvette” error message when the cdi h/s cuvette does not make a proper connection to the cdi h/s probe. in this situation, blood parameter values for hct, hgb, and so2 do not display. if failure of the cdi h/s cuvette connection is recognized after initiation of cardiopulmonary bypass (cpb), the clinician will have to choose between changing out the cuvette (which requires the interruption of cpb for an indeterminate amount of time) or relying on intermittent discreet blood gas analysis values to trend hematocrit/saturation (h/sat) values.
  • Acción
    Terumo are providing users additional instructions to check the cuvette is properly connected before use.

Device

Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulm...
  • Modelo / Serial
    Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulmonary bypass)Catalogue Numbers: 6912, 6913, 6914, 6922, 6923, 6924, CX-AU031XMultiple Lot Numbers affected (see attached)ARTG Number: 138712
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd