Events

Notificaciones De Seguridad De Campo acerca de ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS

Según Health Products Regulatory Authority, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Ireland que fue producido por Hospira Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2013(03)
  • Fecha
    2013-03-27
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/all-hospira-gemstar-family-of-infusers&id=087cf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
    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 circulated six (6) field safety notices (fsns), since august 2011, advising of various issues relating to the gemstar family of infusers which could result in overdose, under-dose or a delay/interruption in therapy.
  • Acción
    1. Ensure that the appropriate personnel are made aware of this notice and the attached Caution in Use FSN.  2. Identify affected pumps.  3. Hospira has implemented the following Restriction for Use into clinical practice for the GemStar Infusion Pumps:  - Do not use on all neonatal populations and infants up to two (2) years of age.  - Do not use on any patients where therapy is delivered at flow rates 2.0ml/hr or less.  4. The manufacturer and the IMB advise users to weigh the risk/benefit to patients associated with the use of these devices when administering critical therapies.  5. Customers should consider the use of an alternative pump, particularly in patients in which an overdose, under-dose or delay/interruption in therapy could compromise patient safety.  6. Follow the manufacturer’s recommendations in the attached Caution in Use FSN.

Device

ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS
  • Modelo / Serial
  • Descripción del producto
    ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    HPRA