Events

Retiro De Equipo (Recall) de Edwards Pressure Monitoring Kit & Set

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Edwards Lifesciences 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-2015-RN-00772-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-25
  • 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-2015-RN-00772-1
  • 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
    A flow restriction issue has been identified in a trifurcated iv set included in the pressure transducer kits. a restriction of the flow of iv fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw. in either instance, the tubing can be exchanged for a new set. this may result in a procedural delay.
  • Acción
    Customers are advised to check their inventory and quarantine any unused affected lots. Contact Edwards Customer Service to arrange for return of any unused product and obtain information about replacement product. This action has been closed-out on 17/08/2016.

Device

Edwards Pressure Monitoring Kit & Set
  • Modelo / Serial
    Edwards Pressure Monitoring Kit & Set, Model Number: PXMK2043(used on patients requiring intravascular, intracranial, or intrauterine pressure monitoring)Lot numbers: 59994210, 60001412, 60020166 & 60030868ARTG Number: 142521
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd