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
    2012-08-23
  • Date de publication de l'événement
    2012-08-23
  • 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_20120823.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 (formerly medley pump module), manufactured by carefusion 303, inc. the manufacturer had identified that there is a potential for the pump module door keypad overlay to become loose, peel away, or separate from the door assembly with keypad part number tc10005926. this could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. when infusion stops, serious injury or death may result. customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation. for details, please refer to the following fda websites http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ ucm316612.Htm and http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm316637.Htm. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 august 2012.

Device

Alaris Pump Module, Model 8100

Manufacturer

CareFusion 303