Events

Alerte De Sécurité sur AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines

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

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
    2015-02-06
  • Date de publication de l'événement
    2015-02-06
  • 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_20150206a.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: gambro ak 200 s and ak 200 ultra s nocturnal home hemodialysis machines australian therapeutic goods administration (tga) posted a medical device safety alert concerning ak 200 s and ak 200 ultra s nocturnal home hemodialysis machines, manufactured by gambro. the manufacturer has received complaints related to a technical error in the ak 200s nocturnal home haemodialysis machines, which will stop all the pumps and close the venous clamp. this has led to 3 cases of 400ml of blood loss and a 2 day treatment delay. a further 21 reported cases resulted in a technical error and a minor treatment delay. one section in the operator’s manuals for the ak 200 s and the ak 200 ultra s instructs the user to contact technical service and to restart the blood pump to return the extracorporeal blood to the patient. restarting the blood pump is however not possible, since the venous clamp is closed and the consequence will be a blood loss according to the local supplier, the affected products are distributed in hong kong. for details, please refer to the following tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00093-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 february 2015.

Device

AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Gambro AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines
  • Manufacturer
    Gambro

Manufacturer

Gambro