Events

Alerte De Sécurité sur EXACTAMIX Compounders

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

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
    2014-07-17
  • Date de publication de l'événement
    2014-07-17
  • 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_20140717.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: baxter exactamix compounders medical device manufacturer, baxter, has issued a field safety notice concerning exactamix compounders with model numbers 2400-dy and 1200-dy. the exactamix compounder uses a universal ingredient (ui) to flush the common fluid pathway at the end of compounding activities. if the ui in an active configuration is changed using the configuration editor rather than following the normally prescribed and supported methods as outlined in the operator manual, a flush of the outlet pump tube will not be initiated by the software. as a result, the original ui may remain in the tube and could be delivered into the next bag. this could lead to an over delivery of the first ui, an under delivery of the subsequent ui, or a delivery of an unintended ui. drug incompatibilities or drug-drug interactions are not reasonably expected with this issue because the uis are normally sterile water for injection, dextrose 50% and dextrose 70%. the worst case scenario would be an unintended rapid infusion of 13.7g of dextrose into a diabetic patient causing hyperglycemia, which may require medical intervention. the manufacturer is updating the em2400 and emi200 operator manuals to provide further clarification – “the configuration editor is to be used only to create and manage non-active configurations. all changes to the ui of an active configuration must be made through the “change ui” functionality described.” according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 17 jul 2014.

Device

EXACTAMIX Compounders
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter EXACTAMIX Compounders
  • Manufacturer
    Baxter

Manufacturer

Baxter