Events

Alerte De Sécurité sur Syringe Pump Green Stream SY-P ARGUS 600 and Argus 600

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

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
    2014-11-25
  • Date de publication de l'événement
    2014-11-25
  • 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_20141125.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: codan argus syringe pump green stream sy-p argus 600 and argus 600 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning syringe pump green stream sy-p argus 600 (firmware version 1-.00-1.51) and argus 600 (firmware versions 3.01-4.32) manufactured by codan argus ag. the safety alert is about a missing pump alarm caused by incorrect pump maintenance. argus 600 was produced in three firmware (fw) versions: version fw1: green stream sy-p argus 600, firmware version 1.00 - 1.51. version fw3 and fw4: argus 600, firmware version 3.01 - 4.32. investigation of an adverse event revealed that fw3/fw4 clamps were used in one european hospital as replacements for broken fw1 clamps resulting in the “syringe alarm” not activating - even though the syringe was mounted improperly it was possible to start the infusion. the manufacturer clarified that the differences between codan argus 600 version fw1 and version fw3/fw4 included mechanical, electronic and further logical changes. as there are design differences between fw1 and fw3/fw4, several mechanical parts inside the driver head are not interchangeable across the fw versions - although they are of a similar shape. the manufacturer is sending a customer letter, user manuals and service manuals to the affected users. as lack of infusion control or delay of therapy is associated with the risk of under infusion of medication with a potential harm of pain, serious injury or death to patient, customers are advised to check the compatibility of firmware and clamps by visual inspection and follow the corrective actions stated in the safety alert. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con475305 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 november 2014.

Device

Syringe Pump Green Stream SY-P ARGUS 600 and Argus 600
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medical Device Safety Alert
  • Manufacturer
    Codan Argus AG

Manufacturer

Codan Argus AG