Events

Rappel de FOLFusor SV 0.5 ml/hr

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare 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-2014-RN-00447-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • 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-2014-RN-00447-1
  • 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
    The direction insert for the folfusor sv 0.5 ml/hr states that infusion rates may be up to 10% greater than the nominal infusion rate of 0.5 ml/hr. flow rate testing indicates that infusion rates may be higher and could result in a 15% greater than nominal infusion rate.
  • Action
    Baxter is notifying their customers that infusion rates may be higher and could result in a 15% greater than nominal infusion rate rather than 10% as stated in the IFU. Baxter is also reiterating the factors that can contribute to over infusion. These factors along with the 15% flow rate accuracy could result in infusion rates in excess of 30% greater than the nominal flow-rate. Baxter is currently investigating options to bring the flow rate into specification.

Device

FOLFusor SV 0.5 ml/hr
  • Modèle / numéro de série
    FOLFusor SV 0.5 ml/hrProduct Code: 2C4700KAll lot numbers up to and including 14B039ARTG Number: 168893
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd