Events

Retiro De Equipo (Recall) de Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps 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-2013-RN-01251-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-02
  • 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-01251-1
  • 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
    1. when the docking station is used in conjunction with a gemstar phase 3 pump (list 13000-xx, 13100-xx or 13150-xx), the potential exists for the pump to fail to power up while connected to the docking station.2. the second situation arises when either a gemstar phase 3 (list 13000-xx, 13100-xx or 13150-xx) or gemstar phase 4 pump (list 13086-xx, 13087-xx or 13088-x) is used in conjunction with both a docking station and an external battery pack accessory (list 13073-xx). with this configuration, there exists a possibility that the gemstar pump will display error code 11/003 indicating excessive input voltage from the external sources. the 11/003 error code will stop infusion if the error occurs when an infusion is in process.
  • Acción
    Hospira is providing work around instructions to mitigate the issues. if the device fails to power up end users are advised to remove the pump from the Docking Station and then power on the pump using 2 fresh AA batteries. To mitigate the 11/003 Error Code, end users must remove the battery pack prior to installing the pump on the docking station. If users are using a docking station in conjunction with an external battery pack accessory (List 13073), Hospira is advising that this practice should not continue. Users are advised to contact Hospira to discuss an appropriate alternative option.

Device

Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps and to ...
  • Modelo / Serial
    Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps and to charge a GemStar battery pack)List Number: 13075-XX-07 and 13075-XX-09ARTG Number: 138118
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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