Alerte De Sécurité sur Plum A+ infusion pumps and Plum A+3 infusion pumps

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 Inc.

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
    2015-03-06
  • Date de publication de l'événement
    2015-03-06
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • 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
    Medical device safety alert: hospira plum a+ infusion pumps and plum a+3 infusion pumps the united states food and drug administration (fda) posted a medical device safety alert concerning plum a+ infusion pumps and plum a+3 infusion pumps [list numbers: 11005 and 20678. serial numbers: refer to the link below] manufactured by hospira inc. the manufacturer is initiating a recall as the system alarms which should sound when a therapy is interrupted may fail to sound. it is possible for a long delay before a health care professional becomes aware of the need to restore therapy. for patients receiving critical intravenous medication, there is a risk of injury resulting from this potential prolonged interruption in therapy. for details, please refer to the following link: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm436770.Htm according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 march 2015.

Device

Manufacturer

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