Events

Alerte De Sécurité sur Dana Diabecare R Insulin Pump

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

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
    2013-02-14
  • Date de publication de l'événement
    2013-02-14
  • 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_20130214.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: sooil dana diabecare r insulin pump the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning dana diabecare r insulin pump, manufactured by sooil development. an update of instructions for use and software controlling minimal basal rate is required in existing/ in-use dana diabecare r insulin pumps having serial numbers beginning ajj, ak, al, and am manufactured after 20 sep 2009. the manufacturer advises that this pump model is unsuitable for delivery of minimal basal rates below 0.04u/h. the manufacturer advises affected users to take the following actions:- users should return the affected devices to the distributors for modification. in the immediate term, users who absolutely require a minimal basal rate of less than 0.04u/h, and whose pumps are so set, should seek an alternative model capable of the rate required and discontinue use of the dana diabecare r model in use as soon as possible, at the same time notifying the manufacturer or the distributor. users with pumps set through “doctor mode” to deliver 0.01u/h should reset them through the same means to deliver a minimal basal rate of not less than 0.04u/h, and notify the manufacturer or the distributor. distributors will contact every pump user to deliver revised ifu and with a view to upgrading the pump software to prevent setting of basal rates below 0.04u/h. pumps whose current software prevents use at minimal basal rate settings below 0.1 u/h (the default value) may be upgraded to provide a minimal basal rate of 0.04u/h only of the user so requires. according to the manufacturer, the affected devices were not distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con231539 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 february 2013.

Device

Dana Diabecare R Insulin Pump
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SOOIL Dana Diabecare R Insulin Pump
  • Manufacturer
    SOOIL Development

Manufacturer

SOOIL Development