Events

Rappel de CADD Legacy 1, Model 6400 Ambulatory Infusion Pump

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smiths Medical Australasia 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-01440-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-11-27
  • 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-01440-1
  • 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
    Smiths medical became aware that a number of cadd legacy 1, model 6400 ambulatory infusion pumps, may contain non-matching serial numbers. specifically, the label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump. the non-matching serial number issue does not impact the functionality of the infusion pumps. the risk to patient health as a result of this issue is negligible.
  • Action
    Smiths Medical is advising users to determine if the serial number on the back of the pump matches the electronic serial number programmed into the pump. If the serial numbers do not match, the pumps are to be returned to Smiths Medical.

Device

CADD Legacy 1, Model 6400 Ambulatory Infusion Pump
  • Modèle / numéro de série
    CADD Legacy 1, Model 6400 Ambulatory Infusion Pump Product Number: 21-6400-51Serial Numbers: 410006, 410007, 410008, 410009, 410010, 410011, 410012 ARTG Number: 109467
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd