Events

Retiro De Equipo (Recall) de Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring Solution Dual Hemo MCable Pods with Revision Index RI15 and RI16 Manufactured between August 2015 to August 2016

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Draeger 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-2017-RN-01269-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-10-04
  • 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-2017-RN-01269-1
  • 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
    Dräger has determined through internal testing that dual hemo mcable pods with revision index (ri) 15 and 16, which are used with the dräger infinity acute care system, may permit liquid ingress inconsistent with their ipx4 rating, which could potentially result in an incorrect measured value of invasive blood pressure. dräger has not received any complaints and is not aware of any negative patient consequences arising from this issue. revisions prior to ri 15 and after ri17 continue to meet the ipx4 standard.
  • Acción
    Dräger are advising users to inspect systems to identify any affected products. Dräger will be providing customers with a sleeve to apply in order to prevent the issue from occurring.

Device

Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring Solution...
  • Modelo / Serial
    Infinity Dual Hemo MCable Pod used with the Infinity Acute Care System (IACS) Monitoring SolutionDual Hemo MCable Pods with Revision Index RI15 and RI16Manufactured between August 2015 to August 2016ARTG Number: 138056
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Draeger Australia Pty Ltd

Manufacturer

Draeger Australia Pty Ltd