Events

Alerte De Sécurité sur Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails infusion pumps

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

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
    2013-06-11
  • Date de publication de l'événement
    2013-06-11
  • 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_20130611.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: carefusion alaris gp, gp guardrails, gp plus & gp plus guardrails infusion pumps it has come to our attention that medical device manufacturer, carefusion, has initiated a field safety corrective action concerning its alaris gp, gp guardrails, gp plus & gp plus guardrails infusion pumps. the affected product references are 80263un01, 80263un01-g, 9002med01, and 9002med01-g, while the affected serial numbers involve those pumps manufactured between dec 2009 and jan 2012. through carefusion’s post market surveillance system, the manufacturer has identified an increased occurrence of stepper motor stalls in a proportion of the alaris gp, gp guardrails, gp plus & gp plus guardrails infusion pump population. the motor stall condition may occur during start up (immediately after the start key is pressed) or during an infusion which may result in the early termination of an infusion. in either case the pump is designed to fail safe giving an audible alarm, a visual alarm displayed on the infusion pump display - “drv1” or “drv2” and the red beacon light on the infusion pump will flash, prompting the infusion pump user to intervene. delay or early termination of an infusion could require intervention especially if critical drugs are being administered. carefusion is aware of several reports where motor stalls have occurred during an infusion but none have resulted in an undesirable clinical outcome. according to the manufacturer, stalls are due to the stepper motor’s front and rear bearings which may not perform as designed after a period of use. the manufacturer plans to replace all the motors of the affected pumps. until the motors can be replaced, users can continue to use potentially affected pumps in accordance with the directions for use. in the unlikely event that users experience a “drv1” or “drv2” error then they should take the pump out of service immediately and contact local carefusion representative. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 11 jun 2013.

Device

Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails infusion pumps
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: CareFusion Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails infusion pumps
  • Manufacturer
    CareFusion

Manufacturer

CareFusion