Events

Retiro De Equipo (Recall) de Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose 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-2012-RN-01039-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-11
  • 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-01039-1
  • 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 volume control knob located on the back of the infuser may not function as described in the system operating manual; the direction for loud and quiet may be reversed. the manual indicates a clockwise rotation of the knob decreases the volume, however on some devices the alarm volume increases when the knob is turned clockwise. while the device will continue to alarm with an audible tone of at least 50dba at the lowest level, inadvertently setting a low tone may result in an audible alarm that is more difficult to hear.
  • Acción
    Hospira is providing work around instructions and will be updating the Instructions for Use (IFU).

Device

Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infus...
  • Modelo / Serial
    Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infusion pump)Plum A+ Pump Version 11.6Catalogue number 611239101Number on pump: 12391/11971Plum A+ Pump Version 13.4 Med Net ABG DriverCatalogue number: 612079201Number on pump 20792ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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