Events

Retiro De Equipo (Recall) de RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas analyser)

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

¿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-01001-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-25
  • 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-2013-RN-01001-1
  • 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
    According to reports received by siemens, users can inadvertently enter a wrong patient id on the demographics screen, which ultimately could lead to a misidentification of the sample. patient id mismatches could be caused by the following:1. inadvertently accepting the pre-selected patient id on the demographics screen.2. overwriting sample demographics by incorrect operation of the patient list button.3. scanning the wrong barcode.4. manually typing the wrong barcode.In each of these cases, failure to check the correct demographics before moving on to the results screen will assign the wrong demographics to the sample being tested.
  • Acción
    Siemens is providing work around instructions for users to follow in the event that patient ID mismatch occurs. A software update will be available for RAPIDPoint 400 series and RAPIDPoint 500 analysers in January 2014. Software version 3.2 and over which are currently available for RAPIDLab 1200 Series analyser addresses the issues. This action has been closed-out on 28/04/2016.

Device

RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas a...
  • Modelo / Serial
    RAPIDPoint 400 Series, RAPIDPoint 500, and RAPIDLab 1200 Series Analysers (diagnostic blood gas analyser)ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA