Events

Rappel de Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulmonary bypass)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Terumo Australia 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-2016-RN-00125-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-10
  • 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-2016-RN-00125-1
  • 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
    Terumo cardiovascular systems (terumo cvs) has received complaints of the cdi system 500 monitor displaying the “h/s disconnect at cuvette” error message when the cdi h/s cuvette does not make a proper connection to the cdi h/s probe. in this situation, blood parameter values for hct, hgb, and so2 do not display. if failure of the cdi h/s cuvette connection is recognized after initiation of cardiopulmonary bypass (cpb), the clinician will have to choose between changing out the cuvette (which requires the interruption of cpb for an indeterminate amount of time) or relying on intermittent discreet blood gas analysis values to trend hematocrit/saturation (h/sat) values.
  • Action
    Terumo are providing users additional instructions to check the cuvette is properly connected before use.

Device

Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulm...
  • Modèle / numéro de série
    Terumo CDI H/S Cuvette (used with the CDI Blood Parameter Monitoring System 500 during cardiopulmonary bypass)Catalogue Numbers: 6912, 6913, 6914, 6922, 6923, 6924, CX-AU031XMultiple Lot Numbers affected (see attached)ARTG Number: 138712
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd