Events

Alerte De Sécurité sur BURETROL Solution Set with 150ml INTERLINK Burette

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
    2014-07-25
  • Date de publication de l'événement
    2014-07-25
  • 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_20140725.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 buretrol solution set with 150ml interlink burette medical device manufacturer, baxter healthcare, has issued a field safety notice (fsn) concerning its buretrol solution set with 150ml interlink burette. the affected product code is 2c7564 with the lot numbers dr13e06019, dr13j24021, dr13j24039 and dr13l11016. the affected products were distributed to customers between 14 march 2014 and 30 june 2014. according to the manufacturer, the voluntary recall was issued due to complaints of separation between the burette chamber and the drip chamber. the root cause for this issue has been identified and resolved. if the separation is not detected before connection with the administration set, there is a risk of contamination of the sterile fluid path which could lead to blood stream infection or sepsis and may be life-threatening. additionally, air may be aspirated into the vascular system, causing venous air embolism, which while is improbable may be life-threatening. there have been no adverse events reported for this issue. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2014.

Device

BURETROL Solution Set with 150ml INTERLINK Burette
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter BURETROL Solution Set with 150ml INTERLINK Burette
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare