Events

Rappel de Colied-Tube INFUSOR System

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-00448-1
  • 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-00448-1
  • 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
    Baxter is issuing a safety alert to notify users of factors that can contribute to over-infusion. when multiple factors are combined infusion rates can be in excess of 30% greater than the nominal flow rate. additionally, end users are being notified of a correction to the instructions for use. recent review of flow rate testing by baxter has identified that the nominal flow rate is achieved when the elastomeric reservoir is positioned 15-20cm below the distal luer lock.
  • Action
    Baxter is reiterating the factors that may impact flow rate as described in the instructions for use (IFU). Baxter is also notifying end users of an amendment to the instructions for with regard to the optimal Elastomeric Reservoir position. End users are advised that nominal flow is achieved when the Elastomeric Reservoir is positioned 15-20cm below the distal luer lock and not when positioned at the same height as stated in the IFU.

Device

Colied-Tube INFUSOR System
  • Modèle / numéro de série
    Colied-Tube INFUSOR SystemProduct Codes:2C1071KJP - Single Day Infusor 2 ml/h System2C1071KJ - Single Day Infusor 2 ml/h System2C1073KJP - Half Day Infusor SV 5 ml/h System2C1075KJP - Two Day Infusor 2 ml/h System2C1080KJP - Multi Day Infusor 0.5 ml/h System2C1082KJP - Seven Day Infusor 0.5 ml/h System2C1082KJ - Seven Day Infusor 0.5 ml/h SystemARTG Number: 46196
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd