Events

Retiro De Equipo (Recall) de All GEMSTAR Family of Infusers; GemStar Infusion System - Single Therapy; GemStar 7 Therapy 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-00247-1
  • Clase de Riesgo del Evento
    Class II
  • 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-00247-1
  • 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
    The proximal and distal pressure sensor calibration can drift resulting in late or missed or false occlusion alarms or reporting of one of the following errors during device setup or infusion:- cassette check – d- cassette check – p- proximal occlusion- distal occlusion- pressure calibration error- bad pressure sensor event- bad pressure sensor state- distal pressure is out of range- proximal sensor is out of range.
  • Acción
    Hospira recommends customers to review the GemStar maintenance schedule and confirm that the Operation test (which includes specific tests for proximal and distal occlusion) is being performed at least on an annual basis. If a device fails either of the proximal or distal occlusion tests at any time immediately remove it from clinical service and return it to and return it to Hospira for repair. Hospira is in consultation with 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
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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