Events

Retiro De Equipo (Recall) de GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a GemStar battery pack)

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-2012-RN-00708-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-07-26
  • 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-2012-RN-00708-3
  • 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
    This is an update to hospira’s previous safety alert notice (tga ref # rc-2011-rn-00812-3) concerning the gemstar docking station. at that time, hospira had received reports from customers of sparking, smoking, charring and electrical shock when using the gemstar docking station. hospira’s investigation concluded that the primary root cause was related to the potential for fluid ingress into the docking station. the design improvements have now been finalised and hospira is replacing all existing docking stations with the new design.
  • Acción
    Customers to advise Sponsor of the number of docking stations held and they will be replaced with the newly designed units.

Device

GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a G...
  • Modelo / Serial
    GemStar Docking Station (Used as an alternate power source for the GemStar pump and to charge a GemStar battery pack)List Numbers: 13075.1 and 13075.3 (2003 - 2006); 13075-24-03, 13075-24-05 & 13075-24-07 (2006 - 2011)ARTG Number: 138118
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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