Events

Alerte De Sécurité sur Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Gambro.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-01-14
  • Date de publication de l'événement
    2015-01-14
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150114.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: gambro artis/evosys dialysis system equipped with sw 8.15.06 and 8.33.02 medical device manufacturer, gambro, has issued a field safety notice concerning artis/evosys dialysis system equipped with sw 8.15.06 and 8.33.02. the manufacturer reminds users of the possibility that foam may be formed in the venous blood circuit when the extracorporeal circuit is primed using on-line priming. the priming volume specified in the operator’s manual and in the dialyzer instruction for use may not be sufficient to completely eliminate any air trapped in the dialyzer fibres. when this occurs, some foam may be created in the venous circuit during patient connection and during the first few minutes of treatment. the condition is visible to the operator. the potential hazard would be presence of some foam in the venous patient line. the air bubble detection system is designed to stop the blood pump when macro bubbles greater than 20 μl are detected. the presence of operator also reduces the risk of foam reaching the patient. according to the local supplier, only the artis dialysis system is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 january 2015.

Device

Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Gambro Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02
  • Manufacturer
    Gambro

Manufacturer

Gambro