Events

Retiro De Equipo (Recall) de Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic medical device (IVD).

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-2017-RN-00137-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-25
  • 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-00137-1
  • 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
    On the abl800 series analysers, the sample type “cord blood” has been changed into the two sample types “cord blood arterial” and “cord blood venous". this change took place with software version 3.1 mr5. despite the selected sample type being correctly displayed on the abl800 series analyser itself, the analyser will transmit the less specific sample type "cord blood" to a his/lis or middleware system. the described error may in a worst-case scenario lead to minor foetal hypoxic stress not being immediately recognised if the clinician was to use data from the his/lis or middleware system to determine treatment. this may cause a minor delay of necessary treatment of the newborn infant.
  • Acción
    Radiometer is advising operators and clinicians using the "cord blood" sample results from a HIS/LIS or a middleware system to determine treatment to be aware that "arterial" or “venous" is not transmitted from the Analysers. Users are further advised that they will be notified when the new software fix is available for installation.

Device

Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic m...
  • Modelo / Serial
    Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic medical device (IVD).All Serial Numbers connected to HIS/LIS or middleware Data Management systemARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd