Events

Alerte De Sécurité sur Logical Hemodraw Closed Blood Sampling Systems

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

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
    2012-12-11
  • Date de publication de l'événement
    2012-12-11
  • 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_20121211c.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: smiths medical logical hemodraw closed blood sampling systems the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning logical hemodraw closed blood sampling systems, manufactured by smiths medical. the manufacturer has become aware of a potential risk of inadvertent introduction of air into the affected device via a porous plug, if the device is used incorrectly. if a user incorrectly orients the zero stopcock when activating the hemodraw reservoir, air can enter the fluid pathway. air in the line, if not properly handled by the clinician, can be introduced into the patient under specific situations, which are highly unlikely according to manufacturer. smiths medical has received no reports of patient injury or death related to this issue. as a precautionary measure, smiths medical is changing its instruction for use to instruct users to fit a non-vented cap to the stopcock after priming. the field safety notice provides these additional instructions to users who have been supplied the affected products. the manufacturer will also supply users with non-vented caps for the affected devices. for details, please refer to the following mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con213146 if you are in possession of the product, please contact your supplier for necessary actions. posted on 11 december 2012.

Device

Logical Hemodraw Closed Blood Sampling Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Smiths Medical Logical Hemodraw Closed Blood Sampling Systems
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical