Events

Rappel de KIMVENT Closed Suction Systems (Tube, tracheal, general-purpose, single-use)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Kimberly Clark Aust Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00827-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-04
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00827-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    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