Events

Retiro De Equipo (Recall) de Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-2015-RN-00012-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-09
  • 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-00012-1
  • 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
    During manufacturing of the sterile, for patient-use, sensation and sensation plus iabc products, the ferrule cap is intended to be removed from the fiber-optic connection at the time of final packaging.Maquet have identified that during the packaging of some demonstration, fiber-optic sensation and sensation plus iabc units, the ferrule cap was not removed. if the fiber-optic connector on an affected non-sterile, non-patient use, demonstration unit is inserted into patient-use maquet cs300, cardiosave intra-aortic balloon pump (iabp) or iabps upgraded with a fiber-optic module, the cap may become dislodged and remain in the fiber-optic receptacle of the pump.If a pump unit is subsequently used with a clincal use fiber optic balloon catheter inserted into the mating connector, the catheter will notmake an electrical connection with the iabp. the catheter will not be recognised as a fiber optic catheter. the system will still be able to pump as a non fiber optic balloon.
  • Acción
    Maquet is providing instructions for the inspection of the demonstration units and the Intra-Aortic Balloon Pumps. End users are requested to inspect and remove the Ferrule caps if present on the pump of demonstration catheter. A Maquet technician will inspect potentially affected devices if required. This action has been closed-out on 11/08/2016.

Device

Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter
  • Modelo / Serial
    Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter ARTG Number: N/A Demonstration model only
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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