Events

Alerte De Sécurité sur Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel 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 Baxter Healthcare Ltd..

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
    2014-12-23
  • Date de publication de l'événement
    2014-12-23
  • 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_20141223a.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 p1.7 cxe single channel pump and colleague p1.7 cxe triple channel pump medical device manufacturer, baxter healthcare ltd. has issued a safety alert for the following infusion pumps: colleague p1.7 cxe single channel pump (product code 2m91617) and colleague p1.7 cxe triple channel pump (product code 2m91637) according to the safety alert, the manufacturer reminds users to reset the manual tube release (mtr) when it is left in the open position. users that do not follow the labeled instructions for resetting the mtr prior to use will be unable to power on the device. this has the potential to lead to a delay in therapy. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 december 2014.

Device

Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump
  • Manufacturer
    Baxter Healthcare Ltd.

Manufacturer

Baxter Healthcare Ltd.