Events

Retiro De Equipo (Recall) de Gemstar Infusion System

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

¿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-2013-RN-01218-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-19
  • 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-2013-RN-01218-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
  • Causa
    Through customer reports, hospira has become aware that patients or unauthorised carers have been able to locate the default keypad lock code for gemstar infusion pumps through internet searches in order to tamper with the programmed infusion parameters. hospira have received no reports relating to this issue in australia. one of the reports overseas resulted in a serious injury.
  • Acción
    Hospira is recommending users change the default keypad lock code upon receipt of the device and prior to delivery to patients, and remove the clinical instructions from the manual to prevent unauthorised access. Hospira will be providing users with an updated System Operating Manual to include the requirement to change the default keypad code.

Device

Gemstar Infusion System

Manufacturer

Hospira Pty Limited
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DHTGA