Events

Retiro De Equipo (Recall) de KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Kimberly Clark Aust 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-00827-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-04
  • 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-00827-1
  • 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
    There is a potential that the thumb valve of a very small percentage of kimvent closed suction systems can remain partially open after suctioning was completed, even though the valve appeared to be closed or in the “locked” position. this situation can result in a partial air leak from the ventilator circuit triggering the ventilator alarm and replacement of the closed-suction device.
  • Acción
    Halyard Health is providing work around instructions to assist end users correct valve leaks caused by this issue. Halyard Health is undertaking an investigation to prevent this issue from occurring. This action has been closed-out on 18/08/2016.

Device

KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use)
  • Modelo / Serial
    KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use)KimVent Closed Suction System - Neonates/Paediatrics, 5F, 6F and 8F Y Adpater5F Lot #: M5067T05 & M5076T4026F Lot #: M5054T5128F Lot #: M5089T503 & M5082T502KimVent Closed Suction System - Adults, 14F, DSELot #: M5085T604KimVent Turbo-Cleaning Closed Suction System - Adults, 12F, DSE Lot #: M5096T306KimVent Turbo-Cleaning Closed Suction System - Adults, 14F, DSELot #: M5080T301ARTG: 129684
  • Manufacturer
    Kimberly Clark Aust Pty Ltd

Manufacturer

Kimberly Clark Aust Pty Ltd