Events

Retiro De Equipo (Recall) de CentraLink Data Management Systems with software versions v13x, v14x, v15x. 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 Siemens 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-2016-RN-01576-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-05
  • 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-2016-RN-01576-1
  • 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
    This issue can only occur when the centralink data management system is connected to the advia workcell or advia labcell automation system and the laboratory information system (lis) does not include sampletype in work order downloaded to centralink. if the automated task to download samples to the laboratory automation system (las) processes immediately after the order is received from the lis, there is a remote possibility centralink may download an order to the advia automation system without specifying the sample type. on advia automation, the value “default” will be downloaded instead of the sample type and this may affect activities that are based on sample type, e.G. sorting for centrifugation based on sample designations. the activity may not be triggered if “default” is received.The risk to health due to this issue is remote given the timing required for the issue to occur and the need for an activity to fail such that an erroneously believable result occurs.
  • Acción
    Siemens is recommending that the LIS specify the sample type in the work order, as the CentraLink system is designed to operate in an environment in which the sample type is specified in the work order that is downloaded from the LIS. A Siemens Technical Support Representative will contact laboratories to review their CentraLink configuration. If the LIS does not include sample type information in the sample orders downloaded to CentraLink and Pre-Tests assigned by sample type are configured on the ADVIA Automation System, the representative will update the configuration.

Device

CentraLink Data Management Systems with software versions v13x, v14x, v15x. An in vitro diagnosti...
  • Modelo / Serial
    CentraLink Data Management Systems with software versions v13x, v14x, v15x. An in vitro diagnostic medical device (IVD).Multiple Siemens Material NumbersARTG Number: 224615
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA