Events

Alerte De Sécurité sur Alaris System Syringe Module

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.

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
    2015-08-25
  • Date de publication de l'événement
    2015-08-25
  • 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_20150825.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 system syringe module the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning alaris system syringe module, manufactured by carefusion. the affected model number is 8110 and material number is 10930269. according to the alert, the manufacturer has received service reports of a channel error on the alaris system syringe module model 8110. a channel error is displayed on the syringe module in association with an audible and visual alarm on the attached point of care unit (pcu) (error code 351.6740); once cleared on the pcu the syringe module remains unresponsive to key presses. this error could occur during an infusion causing an interruption of infusion. whilst connected to an alaris system pcu at the time of error, upon power down and reattachment to any other module the pcu will continue to function as expected, there is no fault or flow on effect to the pcu module. the manufacturer will adjust the syringe drive train assembly on the affected units and replace, if required. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00767-1 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 25 august 2015.

Device

Alaris System Syringe Module
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: CareFusion Alaris System Syringe Module
  • Manufacturer
    CareFusion

Manufacturer

CareFusion