Events

Alerte De Sécurité sur EXACTAMIX Compounder EM2400 and EM1200

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
    2013-08-27
  • Date de publication de l'événement
    2013-08-27
  • 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_20130827a.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 exactamix compounder em2400 and em1200 medical device manufacturer, baxter healthcare ltd, has issued a medical device safety alert concerning the exactamix compounder em2400 and em1200, display module 2400- dy and 1200-dy. baxter has received customer complaints regarding exactamix compounders experiencing an intermittent reset of the internal clock contained within the exactamix compounder display module with part numbers 2400-dy and 1200-dy. this issue only affects the dy display modules. this condition is the result of the battery life being less than anticipated and impacting the internal clock of the compounder. this battery failure results in failure of the exactamix system to alert the user to replace the disposable set after 24 hours of use. users should not rely on this alert to trigger the daily replacement of disposable sets. because daily replacement of disposable sets is standard practice, no adverse health consequence is reasonably expected to result. potential hazards which could result if the disposable sets are not replaced daily include microbial contamination and particulate matter. there have been no reported patient injuries or adverse events associated with this issue. the manufacturer reminds users that confirming the correct time and date is a best practice, and should be performed at the setup of each use. the manufacturer also recommends users to create and review the authorization report daily, which will allow users to confirm their compounder has the correct time and date. in addition, the manufacturer will arrange a swap-out of the current display model with a unit that has had a correction applied. 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 27 august 2013.

Device

EXACTAMIX Compounder EM2400 and EM1200
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare EXACTAMIX Compounder EM2400 and EM1200
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd