Events

Retiro De Equipo (Recall) de Plum 360 Infusion Pump, Software Version 15.01.XX.009 List number 30010-27

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-2015-RN-00986-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-10-13
  • 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-2015-RN-00986-1
  • 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 determined if “yes” is selected at the “new patient” screen, and the program was not cleared prior to powering off the infuser, the distal occlusion pressure setting is assigned a value of 15 psi (775 mmhg) instead of the default value. in addition, the user interface will incorrectly display the default distal occlusion pressure value, which is set at 6 psi (310 mmhg) from the manufacturer, or can be reset in biomed mode or received from the hospira mednet in a custom drug library. the user would not be immediately aware of the unintended occlusion pressure setting unless the user views the current distal pressure value on the infuser display and it is greater than the distal pressure alarm limit. both the current distal pressure and the distal pressure alarm limit are visible on the same user interface screen. this may result in a delay of therapy related to the delay in identifying the occlusion cause, such as kinked tubing.
  • Acción
    Hospira is in the process of developing a software update to correct this issue and will contact you when the new software is available to make arrangements to receive the correction. Until a software update is available, Hospira is recommending that users follow temporary workaround instructions provided in the customer letter for every infusion to prevent this issue from occurring. This action has been closed-out on 31/08/2016.

Device

Plum 360 Infusion Pump, Software Version 15.01.XX.009 List number 30010-27
  • Modelo / Serial
    Plum 360 Infusion Pump, Software Version 15.01.XX.009 List number 30010-27 All serial numbers affectedARTG Number: 234421
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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