Events

Alerte De Sécurité sur INFUSOR Portable Elastomeric Infusion System

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 SA.

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
    2014-03-05
  • Date de publication de l'événement
    2014-03-05
  • 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_20140305.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 infusor portable elastomeric infusion system medical device manufacturer, baxter healthcare sa has issued a medical device safety alert concerning infusor portable elastomeric infusion system with product codes 2c1071kjp, 2c1075kjp and 2c1976kj. all lot numbers within expiration dating are affected. while there have been no changes made to the product, recent review of flow rate testing has shown that the nominal flow rate as labelled is achieved when the elastomeric reservoir is positioned 6-8 inches (15-20 cm) below the distal luer lock and not when positioned at the same height as stated in the directions for use. if the device is positioned according to the current directions for use, a greater than intended flow rate (up to 4%) may occur. therefore, the manufacturer now advises users to position the infusion system’s elastomeric reservoir 6-8 inches (15-20 cm) below the distal luer lock in order to achieve the labelled flow rate. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 march 2014.

Device

INFUSOR Portable Elastomeric Infusion System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter INFUSOR Portable Elastomeric Infusion System
  • Manufacturer
    Baxter Healthcare SA

Manufacturer

Baxter Healthcare SA