Events

Alerte De Sécurité sur Infusion pump CODAN ARGUS 71XV and Syringe pump CODAN ARGUS 606S

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
    2014-09-30
  • Date de publication de l'événement
    2014-09-30
  • 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_20140930a.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 infusion pump codan argus 71xv and syringe pump codan argus 606s the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning infusion pump codan argus 71xv (control software version 5.06) and syringe pump codan argus 606s (control software version 4.80 and 4.81), manufactured by codan argus ag. during internal development testing, the manufacturer has detected a potential software issue regarding the serial communication interface implementation of codan argus 71xv and codan argus 606s. both models have a serial communication interface supporting data retrieval of device and infusion information for storage in patient data management systems (pdms) or similar systems. due to this potential software issue, technical error 2401 (a606s) or 8001 or 8124 (a71xv) may occur on pumps integrated in such systems. a technical error will stop the running infusion, put the pump in a safe mode, and trigger an acoustic and visual alarm. technical errors should be resolved by restarting the pump, re-entering delivery parameters and restarting the infusion. the interruption and delay of therapy is associated with the risk of under infusion of medication with a potential risk of pain, serious injury or death. the manufacturer has corrected the issue within the pump control software revisions, namely codan argus 71xv, version 5.07 and codan argus 606s, version 4.82. the manufacturer advises that implementation of this software upgrade is mandatory across all units mentioned which are connected to a patient data management system (pdms) or similar system. these are available from the manufacturer’s web server. after each firmware upgrade it is necessary to perform the safety standard check. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 30 sep 2014.

Device

Infusion pump CODAN ARGUS 71XV and Syringe pump CODAN ARGUS 606S
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: CODAN ARGUS Infusion pump CODAN ARGUS 71XV and Syringe pump CODAN ARGUS 606S
  • Manufacturer
    CODAN ARGUS AG

Manufacturer

CODAN ARGUS AG