Events

Retiro De Equipo (Recall) de Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio I

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-00494-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-04-27
  • 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-00494-1
  • 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 is issuing a device correction for specific models of the artis dialysis systems in order to update the current software versions to the new software versions. the current version allows for the possibility of resetting and continuing patient treatment without following the instructions for addressing alarm #642, “arterial chamber: level adjustment required.” this will subsequently deactivate the alarm for the remaining treatment time. the new software versions prevent the possibility of continuing the treatment without following the instructions for addressing alarm #642, as detailed in the operator’s manual. users of these devices should adhere to the instructions provided in the current operator’s manual for addressing alarm #642.
  • Acción
    Clinicians may continue to safely use the affected Artis dialysis systems provided they utilise additional vigilance to adhere to the instruction for use for addressing Alarm #642, as documented in the Operator’s Manual until the software correction can be provided to the relevant facilities.

Device

Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio I
  • Modelo / Serial
    Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio IProduct Codes: 110635, 115323 and 115147All Serial NumbersARTG Number: 141189
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd