Events

Retiro De Equipo (Recall) de Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung Bypass System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Cellplex 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-2012-RN-00961-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-09-21
  • 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-2012-RN-00961-1
  • 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 have been reports received of a "fault in motor controller" alarm message. if this occurs, the pump stops, an audible alarm sounds and a visual alarm is displayed as "fault in motor controller" on the system panel. on some occasions the circuit breaker of the pump on the emergency power pack may also trip.
  • Acción
    Cellplex is informing the hospitals to quarantine the roller pumps until the affected components have been replaced by Cellplex. Unaffected roller pumps will be supplied by Cellplex as loan units, if required

Device

Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung ...
  • Modelo / Serial
    Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung Bypass System)S5 Single Roller Pump 150Product Code: 10-80-00Serial Number: 10E06300, 10E06301 and 10E06302S5 Double Roller Pump 85Product Code:10-85-00Serial Number: 10E51883ARTG Number: 108387
  • Manufacturer
    Cellplex Pty Ltd

Manufacturer

Cellplex Pty Ltd