Events

Retiro De Equipo (Recall) de Prismaflex Control Unit (with software versions prior to 8.10)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare Pty Ltd.

¿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-00385-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-04-26
  • 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-00385-1
  • 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.
  • Notas adicionales en la data
  • Causa
    Baxter healthcare has received reports of device operators failing to adhere to the instructions for use (ifu) pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. if not followed, severe blood loss may occur with a potentially fatal outcome.
  • Acción
    Baxter will be installing a free software upgrade at the users' facility. In the interim, Baxter is advising users that they may continue to use the affected units by following the instructions provided in the Prismaflex Operator’s Manual and the on-screen instructions when unloading the disposable set. Specifically, users should ensure that all lines are clamped and the patient is disconnected before proceeding with unloading.

Device

Prismaflex Control Unit (with software versions prior to 8.10)
  • Modelo / Serial
    Prismaflex Control Unit (with software versions prior to 8.10)Prismaflex 4.11Product Code: 113082Prismaflex 6.10 ROWProduct Code: 114489Prismaflex 7.XX ROWProduct Code: 114870All Serial NumbersARTG Number: 142047
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd