Events

Retiro De Equipo (Recall) de LQT6283LB In-line leucoreduction system for red cell concentrates with LCRD2 Leucoflex soft filter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por MacoPharma 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-2016-RN-01573-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-13
  • 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-01573-1
  • 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
    Macopharma was informed of a number of fast filtrations for reference npt6280la that includes the lcrd2 filter. this has led to some instances of ineffective filtration through the media of the lcrd2 filter. the frequency has increased to an average of 100 dpm (defect per million) (0.01%) on production from the month of june 2016. this sporadic defect is linked to a partial absence of the weld in the media caused by poor positioning (fold or gap) of the last polyester layer in the mattress. this defect is easily detectable during the initial stages of filtration by the presence of blood moving into the downstream chamber (exit side of filter) and tubing at the central point of the filter during priming. this leads to a very quick filtration.
  • Acción
    Macopharma is advising customers that they should pay particular attention to the priming of the filter. Unaffected filters may continue to be used. All priming faults (direct passage) must be discarded and should be returned to Macopharma Australia for analysis. Macopharma will supply a credit note for the loss of affected product. This action has been closed out on 16 June 2017.

Device

LQT6283LB In-line leucoreduction system for red cell concentrates with LCRD2 Leucoflex soft filter
  • Modelo / Serial
    LQT6283LB In-line leucoreduction system for red cell concentrates with LCRD2 Leucoflex soft filterARTG Number: 142856
  • Manufacturer
    MacoPharma Australia Pty Ltd

Manufacturer

MacoPharma Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Macopharma
  • Source
    DHTGA