Events

Alerte De Sécurité sur Zevex Ambulatory Infusion PumpsPainsmart IOD, 6000 CMS, and 4000 CMS

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

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
    2011-11-15
  • 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_20111115b.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
    Health canada type i recall: zevex ambulatory infusion pumpspainsmart iod, 6000 cms, and 4000 cms it has come to our attention that the health canada has issued a type i recall to remind healthcare providers and patients that painsmart iod, 6000 cms and 4000 cms (ambulatory infusion pumps), which are manufactured by zevex inc. (also traded as moog medical devices group), may give an inaccurate infusion. the accuracy of infusion with a syringe varies widely depending on the medication and stiction between the barrel and plunger of individual syringes. the effects of the variables have made the accuracy difficult to evaluate as each condition produces differing effects from the syringe variables. therefore, zevex is not confident in providing accuracy percentages for syringes as they may be misleading if the application conditions are also considered. as a result, the labeling will be modified to indicate the accuracy of delivery from a syringe cannot be guaranteed. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/ rec-ret_md-im_date_oct-dec_2011-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Zevex Ambulatory Infusion PumpsPainsmart IOD, 6000 CMS, and 4000 CMS
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Zevex Ambulatory Infusion Pumps Painsmart IOD, 6000 CMS, and 4000 CMS
  • Manufacturer
    Zevex Inc.

Manufacturer

Zevex Inc.
  • Société-mère du fabricant (2017)
    Moog Inc
  • Source
    DH