Events

Retiro De Equipo (Recall) de Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). 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-01073-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-22
  • 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-01073-1
  • 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
    There is the potential for mismatched sample id's under a rare circumstance where the host computer connected to the instrument sends a measurement order irregularly to the instrument. the host computer displays a 'time out' error and when measuring the next sample displays the error 'host computer order is wrong' and overwrites the previous sample id with the current sample being measured. there is the potential for a mis-diagnosis as a result of the error, however there have been no reported injuries as a result of the issue.
  • Acción
    Siemens is advising users to repeat the measurement of all samples in an affected sample rack when the instrument displays the error 'HC Order is wrong". A look-back at patient results is at the discretion of the laboratory director. If the error occurs, users should contact the Host Computer Vendor to confirm the interface protocol is running correctly.

Device

Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnos...
  • Modelo / Serial
    Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnostic medical device (IVD)Siemens Material Number : 10488064, 10488062All software versionsARTG Number:179939
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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