Events

Rappel de Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL

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-01299-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-10-17
  • 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-2017-RN-01299-1
  • 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 has become aware that certain non-flow-stop cadd medication cassette reservoirs may have been manufactured with an incorrect pressure plate. this product is designed without an arch, but the defective product has a plate with an arch.There is a risk that under delivery of medication may result from the tubing becoming partially or completely occluded when the cassette is attached to the pump. the clinician is not aware of the issue because the pump will continue to operate as if it is infusing medication without alarming for an occlusion.
  • Action
    Smiths Medical is advising users to quarantine remaining stock of the affected product for return for credit. It is recommended that users transition to an equivalent flow stop version of the CADD Medication cassettes.

Device

Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL
  • Modèle / numéro de série
    Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL50mL CADD Medication CassetteItem Code: 21-7001-24100mL CADD Medication CassetteItem Code: 21-7002-24 100mL CADD Medication Cassette, YellowItem Code: 21-7100-24Multiple Lot Numbers ARTG Number: 145297
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd