Events

Retiro De Equipo (Recall) de Communication Engine in Plum A+ and A+3 Infusion Pump

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-00140-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-02-14
  • 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-00140-1
  • 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
    Some plum a+/a+3 devices contain a communication engine which communicates wirelessly with hospira mednet over a facility's local area network (lan). hospira has received several reports indicating that the communication engine in some plum a+/a+3 devices experiences difficulty downloading a custom drug library as indicated by an appropriate error message.
  • Acción
    Hospira are advising users that if a custom drug library fails to download and experiences an error message, please report the issue to Hospira. Hospira will make arrangements to identify and correct the Communication Engine.

Device

Communication Engine in Plum A+ and A+3 Infusion Pump
  • Modelo / Serial
    Communication Engine in Plum A+ and A+3 Infusion Pump Plum A+Pump: 12391 & 20792Communication Engine Modules:20677 & 20791 (respectively)Plum A+3Pump: 20678Communication Engine Modules: 20678ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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