Events

Retiro De Equipo (Recall) de Macopharma blood bags

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-00994-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-16
  • 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-00994-1
  • 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
    Side slits and hanging holes have been reported missing on the final red cell pack of some bottom and top (bat) systems.The slits cut into the cv1014 pack are used to store the crossmatch line ‘pig-tails’. the hanging loop is used during the inversion of the pack to run additive into the concentrate red cells. this recall action was undertaken prior to consultation with the tga.
  • Acción
    Macopharma is advising users that systems that are found to be absent of side slits and hanging loops should not be used, and that pack traceability is reported to to Macopharma for packs that cannot be returned. This action has been closed-out on 16/09/2016.

Device

Macopharma blood bags
  • Modelo / Serial
    Macopharma blood bagsProduct Code: LQT6283LBMultiple batches affectedARTG Number: 142856
  • Manufacturer
    MacoPharma Australia Pty Ltd

Manufacturer

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