Events

Rappel de Alaris System Pump module (LVP), Mechanism Sub-assembly and Kit Assembly

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CareFusion Australia 316 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-2017-RN-01312-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-11-03
  • 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-2017-RN-01312-1
  • 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
    Becton dickinson (bd) has identified an issue with the alaris pump module regarding increased or decreased flow rates that have occurred in pumps with mechanical assemblies manufactured between november 2011 and march 2012.The component of the alaris pump module causing this issue is the bezel assembly, specifically the bezel posts. the affected posts may have cracking in one or more posts that connect the mechanism frame to the bezel assembly. separation of one or more bezel posts may prevent the device from delivering an accurate amount of fluid through the pumping cycle, resulting in an over or under infusion.Zero reports relating to this issue have been received in australia.
  • Action
    BD has assessed the risk of this issue and determined that the affected product can still be used until this correction is carried out. However, BD strongly recommends that clinicians increase their level of vigilance when using impacted pumps. Additionally, clinicians should remove the pump from service if it shows signs of infusion at an unexpected rate. Use non-affected, or remediated, devices in high risk areas if possible. In addition, to the best of BD’s ability, BD will work with customers to identify and mark individual pumps that have not yet been remediated. BD will replace the mechanical assembly of the affected serial numbers at no charge. BD will be in contact with all affected customers to initiate the scheduling process for the remediation.

Device

Alaris System Pump module (LVP), Mechanism Sub-assembly and Kit Assembly
  • Modèle / numéro de série
    Alaris System Pump module (LVP), Mechanism Sub-assembly and Kit AssemblyAlaris System Pump module (LVP) 8100 manufactured between 4 November 2011 and 11 March 2012Alaris Pump module LVP Mechanism Sub Assembly manufactured by the supplier between 4 November 2011 and 14 March 2012Part Number: 10942012Alaris Pump module Bezel Kit Assembly manufactured by the supplier between 4 November 2011 and 26 March 2012Part Number: 10964559ARTG Number: 146664
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd