Events

Retiro De Equipo (Recall) de All GemStar Family of Infusers: GemStar Infusion System - Single Therapy, GemStar 7 Therapy Infusion SystemGemStar Infusion System - Single Therapy

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-00246-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-04-12
  • 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-00246-1
  • 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
    During infusions at flow rates of less than 2.0ml/hr , the motor assembly may rotate backwards (roll back), capturing additional medication that will be delivered resulting in over-infusion. additionally, users may receive x09/001 backward motor movement alarms during the device’s power on self test (post) or during an infusion. this alarm will invoke visual and audible warnings to the user and the infusion will not begin or an active therapy will stop, resulting in a delay or interruption in therapy.
  • Acción
    Hospira is advising customers to refrain from using GemStar Infusion pumps on all Neonatal patient populations and infants up to 2 years of age, and any patients where therapy is delivered at flow rates less than 2.0mL/hour. If the GemStar device displays an X09/001 error, customers are advised to immediately remove it from clinical service and return it to Hospira for repair. Hospira is in consultation with the TGA for any further action. Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which delay/interruption in therapy or under/over infusion could result in significant injury or death.

Device

All GemStar Family of Infusers: GemStar Infusion System - Single Therapy, GemStar 7 Therapy Infus...
  • Modelo / Serial
    All GemStar Family of Infusers: GemStar Infusion System - Single Therapy, GemStar 7 Therapy Infusion SystemGemStar Infusion System - Single TherapyCatalogue number: 611308801Number on pump: 13088/13150GemStar 7 Therapy Infusion SystemCatalogue number: 611308701Number on pump: 13087/13000
  • 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