Events

Retiro De Equipo (Recall) de Sapphire Multi Therapy Pump with software Rev09Ver07 (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-2013-RN-01041-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-10
  • 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-2013-RN-01041-1
  • 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 manufacturer, q core, has received three similar reports from a customer, who experienced deviations from the duration of treatment, as programmed. the incidents occurred while using the multi step mode. while no patient injuries or deaths have been reported, the issue may result in incorrect therapy. specifically, the issue only occurs when the following conditions are met simultaneously:- multi-step mode is used, and- the pump is not plugged into an ac power outlet and is operating on battery power only, and- the pump backlight is turned off.The factory default for the backlight configuration in the sapphire multi therapy pump is on; therefore unless the pump backlight is turned off, the issue will not occur.
  • Acción
    Q Core has developed a software solution (Rev09Ver08) to address the issue. Until the Sapphire Multi Therapy pumps have been updated with the new software, users are required to: (i)Use the Sapphire Multi Therapy pump plugged into an AC power outlet; and/or (ii)Use the Sapphire Multi Therapy pump with the backlight configuration set to ON or PARTIAL. It is recommended to check all pumps that are in current operation in order to ensure correct setting of the backlight. Please note that in pumps configured with backlight OFF the screen will darken completely after 1 minute of screen inactivity. The pumps configured to have the backlight OFF require reconfiguration of the backlight setting to ON.

Device

Sapphire Multi Therapy Pump with software Rev09Ver07 (Infusion Pump)
  • Modelo / Serial
    Sapphire Multi Therapy Pump with software Rev09Ver07 (Infusion Pump)Hospira List Number: 163113601ARTG Number: 201499
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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