Events

Alerte De Sécurité sur BD Phoenix™ System Software and BD Phoenix™ Update Disks

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

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
    2012-04-30
  • 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_20120430b.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
    Field safety notice: bd phoenix™ system software and bd phoenix™ update disks medical device manufacturer, bd. has initiated a field safety corrective action concerning certain bd phoenix™ system software and bd phoenix™ update disks. according to the manufacturer, through customer feedback and subsequent investigation by their in-house technical experts, they have identified an increase in vancomycin-resistant enterococcus faecium strains that may exhibit erroneous results (false susceptible or false intermediate interpretations) in the vancomycin well on all pmic or pmic/id panels.  these strains of e. faecium show different growth patterns in the phoenix system than those previously identified. all gram positive panels containing vancomycin are affected by this action therefore this notice is applicable to all current and future product lots that contain vancomycin until further notice. this issue is related only to ‘vancomycin susceptible or vancomycin intermediate’ e. faecium results.  all ‘vancomycin resistant’ results for e. faecium and all mic results for organisms other than e. faecium continue to be interpreted correctly. at the time being, an epicare rule will be installed by bd to suppress vancomycin susceptible and vancomycin intermediate results for e. faecium from being reported to lis. a more permanent software solution is being developed to address the issue. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

BD Phoenix™ System Software and BD Phoenix™ Update Disks
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD Phoenix™ System Software and BD Phoenix™ Update Disks
  • Manufacturer
    BD

Manufacturer

BD