Events

Alerte De Sécurité sur Plum 360 Infusion System

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

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
    2017-06-27
  • Date de publication de l'événement
    2017-06-27
  • 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_20170628b.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: icu medical hospira plum 360 infusion system the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning hospira plum 360 infusion system [list number: 30010; multiple serial numbers], manufactured by icu medical. the manufacturer has identified a potential for the connectivity engine (ce) module to disengage from the main chassis. in a rare situation, this could lead the plum 360 infuser to power down without an alarm notification resulting in a delay of either initiation of a therapy or interruption of an active infusion. in rare circumstances, these conditions could lead to serious adverse health consequences related to changes in a patient’s vital signs. to date, the manufacturer has not received any reports of serious injury or death associated with this issue. the manufacturer will be contacting users and arranging for inspection of all affected plum 360 infusers. the chassis will be replaced as required. in the interim, the manufacturer is advising users to inspect the affected plum 360 infusers using the instructions provided in the customer letter in order to verify that the infuser is working. if at the end of testing a loose ce module or blank display is observed, the infuser is to be removed from service, and the user is to record the s/n and contact the manufacturer’s service department. otherwise, the infuser can be returned to clinical use. if the plum 360 infuser powers down without an alarm notification during infusion, use another plum 360 infuser for infusion or consider use of alternative infusion methods based on the clinical situation. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2017-rn-00729-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 june 2017.

Device

Plum 360 Infusion System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: ICU Medical Hospira Plum 360 Infusion System
  • Manufacturer
    ICU Medical

Manufacturer

ICU Medical