Events

Alerte De Sécurité sur Easypump C-bloc RA OnDemand

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

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
    2013-05-21
  • Date de publication de l'événement
    2013-05-21
  • 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_20130521a.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: b. braun easypump c-bloc ra ondemand the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning easypump c-bloc ra ondemand, manufactured by b. braun medical limited. the affected article number is 4440008 and the affected batch numbers are 152803,182313 and 192472. the manufacturer recently determined that in a small quantity of easypump c-bloc ra pump with ondemand bolus button, the button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. in this condition, the patient may receive continuous infusion at a rate greater than expected. the manufacturer’s complaint analysis determined that approximately 0.04% of the pumps (i.E.: approximately 4 out of 10,000) may develop this condition. if this condition occurs, it may not be detected during filling or priming of the pump. the use of a pump with this condition may result in over medication of the patient and may potentially result in serious patient injury. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con273701 according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 21 may 2013.

Device

Easypump C-bloc RA OnDemand
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: B. Braun Easypump C-bloc RA OnDemand
  • Manufacturer
    B. Braun Medical Limited

Manufacturer

B. Braun Medical Limited