Events

Alerte De Sécurité sur Infusomat Space Pump - US Version Infusion 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 B. Braun.

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
    2012-03-09
  • 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_20120310c.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: b. braun infusomat space pump - us version infusion pump the food and drug administration (fda), united states, has issued a class i recall on b. braun infusomat space pump - us version infusion pump, model # 8713050u. fda reported that the affected device has a potential for breakage of anti free flow clip catch when the iv set anti free flow clip is incorrectly inserted into the pump and the pump door forced to be closed. if the clip catch is broken and the door opened, free flow protection is still ensured. however, after the set is manually removed from the pump without the closure of the iv set roller clamp, the anti free flow clip may not re-engage the tubing thereby leaving an open fluid path and creating a potential for free flow. when the pump and iv set are operated in accordance with the instructions for use, the potential for free flow is fully mitigated. according to the local supplier, the affected device is not distributed in hong kong. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/enforcementreports/ucm292057.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

Infusomat Space Pump - US Version Infusion pump

Manufacturer

B. Braun