Events

Retiro De Equipo (Recall) de cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Radiometer Pacific 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-2014-RN-01201-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-11
  • 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-2014-RN-01201-1
  • 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
    Radiometer has become aware that the ccrea results for qc decreases to below the lower acceptance limit within the lifetime of the crea membranes. this has been experienced on membranes down to five days after installation of new membrane units.
  • Acción
    Radiometer is advising their customers to perform one quality control measurement using S7835 AutoCheck 6+, level 1 (Item 944-094), on already installed Crea membrane units to verify the cCrea performance. If the QC result is out of range, please install new Crea A and Crea B membranes. Until further notice the following must be carried out every 24 hours: - Perform one quality control measurement using S7835 AutoCheck 6+, level 1 (944-094) to verify the cCrea performance. - If the QC result is out of range, new Crea A and Crea B membranes must be installed. This action has been closed-out on 05/08/2016.

Device

cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range
  • Modelo / Serial
    cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range Item Number: 942-073ARTG Number: 229300
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd