Events

Retiro De Equipo (Recall) de Sysmex CS-5100 Analyser. 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-2017-RN-01098-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-23
  • 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-01098-1
  • 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 a short circuit between the pcb (printed circuit board) and heater transistor or a malfunction of the transistor with the sysmex cs-5100. this may lead to smoke from the instrument, and in a worst case scenario, the overcurrent damaging the pcb, which may lead to a melting of the transistors until the instrument is powered off. this failure mode will occur if all of the conditions below are met:- pcb protection component blocks overcurrent by the short circuit- pcb protection component has a breakdown after a certain period with the instrument turned on- the overcurrent is throughout the pcb, which may lead to burn out unless the instrument is powered off.
  • Acción
    Follow the instructions provided by Sysmex and confirm receipt of the information issued in August 2017. Complete and return the Response Form attached to the customer letter by Friday 22nd of September 2017. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files and forward this information to all parties that may use a Sysmex CS-5100 system. A Siemens field service representative will visit and disconnect the connector on the PCB.

Device

Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Sysmex CS-5100 Analyser. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10709128Serial Numbers before 24425ARTG Number: 179939
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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