Events

Retiro De Equipo (Recall) de PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those included in tubing sets.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge Australia 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-00978-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-08-08
  • 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-00978-1
  • 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
    The plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegia and / or crystalloid cardioplegia solutions during extracorporeal circulation. the plegiox heat exchanger consists of two liquid circulations strictly separated from each other by a separating barrier to separate both liquids from each other and to effect thermal transfer at the same time; the design of the plegiox uses hollow fibres made of polyurethane. hollow fibres serve as barrier separating the circulating liquids while effecting thermal transfer. maquet cardiopulmonary gmbh (mcp) internal investigations have revealed that the specification of the performance factor (pf) at flow rates of 1 litre per minute is not always maintained as defined in instruction for use (ifu). deviations up to minus 20% were identified during in-house testing. zero adverse events have been reported in relation to this insufficiency.
  • Acción
    Getinge seeks to notify users that: When using the PLEGIOX, the flow rate should be no higher than 500 ml/min to ensure reasonable performance.

Device

PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those ...
  • Modelo / Serial
    PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those included in tubing sets.Reference Numbers: 703006246, 703006285, 703006317ARTG Number: 158781
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA