Events

Retiro De Equipo (Recall) de Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infusers (general purpose infusion pump).4200 PCA Infuser; List Number 610F78201PCA and PCA with MedNet Software Infusers; List Number: 612070901

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-00936-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-09-28
  • 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-00936-1
  • 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
    Hospira has received reports overseas from customers related to the improper use of the slide clamp when the syringe (vial) was manipulated or when stopping infusion during delivery of fluids. users are being informed of the correct usage of the slide clamp and/or syringe manipulation to prevent over delivery.
  • Acción
    Customers are being advised of the correct use of the c slide clamp and/or syringe manipulation to prevent over delivery.

Device

Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infuse...
  • Modelo / Serial
    Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infusers (general purpose infusion pump).4200 PCA Infuser; List Number 610F78201PCA and PCA with MedNet Software Infusers; List Number: 612070901ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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