Events

Alerte De Sécurité sur COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7

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

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
    2015-05-08
  • Date de publication de l'événement
    2015-05-08
  • 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_20150508.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: baxter healthcare colleague single channel cxe pump, v1 .7 medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning colleague single channel cxe pump, v1.7 with item code 2m91617 and serial number 21010369dl. according to the safety alert, the issue is related to the use of an incorrect user interface module (uim) during service. the use of the incorrect spare part could lead to a pump shutdown without an alarm (silent shutdown) if the uim printed circuit board assembly fails. this defect could occur before starting or during therapy that could potentially cause a delay of infusion or interruption of infusion. according to the local supplier, the affected products are distributed in hong kong. the manufacturer will collect the affected device for correction. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 may 2015.

Device

COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare