Events

Rappel de Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter Monitoring System 500

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Lovell Surgical Supplies International 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-00187-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-17
  • 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-2016-RN-00187-1
  • 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
    The terumo cdi h/s cuvette is included in some cardiopulmonary bypass packs supplied by lovell surgical supplies international.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 recognised 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 haematocrit/saturation (h/sat) values.
  • Action
    Lovell Surgical Supplies is providing users additional instructions to check the cuvette is properly connected before use. Thia action has been closed-out on 19/01/2016.

Device

Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter...
  • Modèle / numéro de série
    Cardiopulmonary Bypass Packs containing Terumo CDI H/S Cuvettes used with the CDI Blood Parameter Monitoring System 500Multiple Product Codes affectedMultiple Batch Numbers affectedARTG Number: 158341
  • Manufacturer
    Lovell Surgical Supplies International Pty Ltd

Manufacturer

Lovell Surgical Supplies International Pty Ltd