Events

Retiro De Equipo (Recall) de GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)

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-2014-RN-00152-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-17
  • 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-2014-RN-00152-1
  • 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 complaints, hospira has become aware that in the gemstar (phase 3) infusion pumps, the connection between the beeper subassembly and the pump may fail. the gemstar infusion pump will identify this failure during the “self-test” while powering up which will result in a beeper error. this beeper error will display on the device with a service error code “code 10/001/000”. this beeper error (service code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
  • Acción
    Customers are advised that there is no need to return their GemStar Phase 3 Infusion pumps at this time. If a Beeper Error occurs during power up, customers are asked to remove the device from service immediately and contact Hospira to arrange for a loan pump.

Device

GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)
  • Modelo / Serial
    GemStar 7 Therapy Pump and GemStar Pain Management Pump (Phase 3 pumps)List Numbers: 13000 and 13150ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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