Events

Rappel de BD MAX Instruments. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Becton Dickinson 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-2013-RN-00582-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-28
  • 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-2013-RN-00582-2
  • 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
    Bd has determined during instrument testing a small portion of instruments were built with the wrong power module component, which is rated 1 amp instead of the required 10 amp. bd has advised that the user would not be aware of this defect, as the instrument will function as expected, with no impact on specimen processing or results reporting. however, the component inside the instrument will get hot, and over time the component will fail, which could cause downtime and require a service visit.The bd max instrument operates with a current between 1.3 and 3 amps. in assessing the potential impact of installing a 1 versus 10 amp power input module, the manufacturer ran the 1 amp power input module at various current levels and measured the temperature of the component, with the following results:1.9 a for 14 minutes – 45°c3.3 a for 20 minutes – 66°c4.4 a for 14 minutes – 80°c. the component is rated by its manufacturer for use up to 85°c.
  • Action
    A BD service representative will correct affected systems on-site after undertaking a system check to determine if there are any affected systems in the field.

Device

BD MAX Instruments. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    BD MAX Instruments. An in vitro diagnostic medical device (IVD)Catalogue number: 441916Serial numbers: CT0182, CT0213 & CT0174
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd