Events

Alerte De Sécurité sur Alaris Pump Module, Model 8100

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par CareFusion 303.

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
    2012-08-24
  • Date de publication de l'événement
    2012-08-24
  • 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_20120824.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: carefusion alaris pump module, model 8100 the united states food and drug administration (fda) has issued a class i recall concerning alaris pump module, model 8100, manufactured by carefusion 303, inc. the manufacturer has identified a potential risk associated with the alaris pump module model 8100. carefusion has received reports of customers experiencing motor stalls during infusion with alaris pump module (model 8100) manufactured between august 2010 and july 2011. most of the motor stalls reported appear to occur intermittently at high infusion rates (typically over 900 ml/hr) but carefusion cannot rule out the possibility of occurrence at lower infusion rates. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following websites http://www.Accessdata.Fda.Gov/scripts/enforcement/ enforce_rpt-event-detail.Cfm?action=detail&id=55121&w= 08222012&lang=eng http://www.Carefusion.Com/customer-support/alerts-notices/ medical-device-recall-alaris-pump-module-8100-intermittent-motor- stall.Aspx. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 24 august 2012.

Device

Alaris Pump Module, Model 8100

Manufacturer

CareFusion 303