Events

Rappel de Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity 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 Admedus Australia 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-2018-RN-00367-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-18
  • 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-2018-RN-00367-1
  • 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
    Admedus has been made aware that some users have been experiencing problems when priming the infusion lines prior to connecting them to the patient. in clinical practise, nurses will generally “prime" the lines some time before connecting to the patient. during the time between priming and connection to the patient, observations of bubbles and lost fluid have been made, even when the clamp and roller are closed. admedus have identified that this issue is isolated to the lines containing a 0.2 micron filter when priming of the line has been performed with an inverted filter.
  • Action
    Admedus are advising they are providing customers with a revised Instructions for Use (IFU) which includes information on correct priming and storage of the lines. A side clamp will be added to the distal end of the set - between the Y-site and the Luer to prevent leakage even if the operator does not follow the priming and storage instructions outlined in the IFU. Until the re-designed lines are available (expected March-May 2019), side clamps will be provided for clinicians to add on the line prior to priming.

Device

Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Use
  • Modèle / numéro de série
    Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Use Product Code: ALPPK1SVJ1FARTG Number: 274187(Admedus Australia - Electric infusion pump administration set)
  • Manufacturer
    Admedus Australia Pty Ltd

Manufacturer

Admedus Australia Pty Ltd