Events

Retiro De Equipo (Recall) de Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Gambro 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-2014-RN-01214-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-13
  • 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-2014-RN-01214-1
  • 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
    Gambro renal products is advising the customers of the possibility of a tear in the individual sterile barrier packaging on some of its polyflux revaclear/ polyflux revaclear max dialysers. the nature of the defect is such that it is isolated to the package only; the dialyser itself is not damaged. the tears are only on the printed white tyvek side of the packaging and are readily visible. a tear in the package is a sterility breach; if the product is then used to treat a patient, there is a remote risk of infection. however, that risk is extremely unlikely. even if the packaging is compromised, the protection caps on the blood ports of the dialyser are protecting the blood fluid path of the device from a potential contamination. gambro has not received any reports of adverse patient events.
  • Acción
    Gambro Pty Ltd is requesting the customers to inspect their inventory, discontinue use immediately and quarantine the affected product. Gambro will arrange for the affected stock to be recovered and replacement stock, or a credit note, issued.

Device

Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)
  • Modelo / Serial
    Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)Product Codes: 110633 & 110634Multiple lot numbers are affectedARTG Number: 194549
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd