Events

Retiro De Equipo (Recall) de Plum 360 Infusion Pump, software version 15.02

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-2017-RN-00001-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-05
  • 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-2017-RN-00001-1
  • 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
    Two software issues have been identified with the plum 360 infusion pump, software version 15.02, namely:issue 1 - the pump software incorrectly generates a “depleted battery” alarm instead of a “replace battery” alarm when the battery has a near end of life charge capacity. the expected performance of the infusion pump and software is for the infusion pump to generate a “replace battery” alarm when the software has determined the battery has reached a near end of life charge capacity. issue 2 – when ac power is lost and quickly resumed, the pump software incorrectly classifies the event as an e323 alarm condition. this result in an interruption of any ongoing therapy and the infusion pump will restart (reboot).
  • Acción
    Hospira is advising users to connect the infusion pump to AC power and turn the pump on. They are requested to replace the battery if they see the “Replace Battery: Keep Plugged into AC! Service battery / replace pump” message. Users are also requested to replace the battery if they see the “Depleted Battery! Plug into AC now!” message while the pump is in operation. For battery replacement, users are requested to either send it to their in-house engineering department in the first instance and if further assistance is required, to contact the Hospira Service Centre.

Device

Plum 360 Infusion Pump, software version 15.02
  • Modelo / Serial
    Plum 360 Infusion Pump, software version 15.02List Number: 30010ARTG Number: 234421
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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