Events

Alerte De Sécurité sur All Plum A+ family of Infusers

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

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
    2011-10-04
  • 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_20111005.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Field safety notice: hospira all plum a+ family of infusers hospira has issued urgent device recall on plum a+™ family of infusers. the manufacturer has received customer reports involving two safety issues: (1) rebooting of the infusion pumps, and (2) the incorrect seating of the regulatory closer potentially causing unrestricted flow. the first issue is related to the continuous recycling and/or rebooting of plum a+ devices when the "backlight intensity" and/or "display contrast" settings for the lcd display have been adjusted from default setting. this condition can cause a delay in therapy because the clinician would not be able to start the device due to the continuous recycling and/or rebooting. the second issue is related to incorrect seating of the regulator closer that potentially causes unrestricted flow of the infusion pump when the cassette door is opened. the condition may lead to life-threatening adverse events. to correct the issues, hospira will provide software upgrade and technical checkups to affected customers. according to the local supplier, plump a+ infusion pumps have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

All Plum A+ family of Infusers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira All Plum A+ family of Infusers
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DH