Events

Rappel de Communication Engine in Plum A+ and A+3 Infusion Pump

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hospira Pty Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00140-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-02-14
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00140-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
    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
  • Cause
    Some plum a+/a+3 devices contain a communication engine which communicates wirelessly with hospira mednet over a facility's local area network (lan). hospira has received several reports indicating that the communication engine in some plum a+/a+3 devices experiences difficulty downloading a custom drug library as indicated by an appropriate error message.
  • Action
    Hospira are advising users that if a custom drug library fails to download and experiences an error message, please report the issue to Hospira. Hospira will make arrangements to identify and correct the Communication Engine.

Device

Communication Engine in Plum A+ and A+3 Infusion Pump
  • Modèle / numéro de série
    Communication Engine in Plum A+ and A+3 Infusion Pump Plum A+Pump: 12391 & 20792Communication Engine Modules:20677 & 20791 (respectively)Plum A+3Pump: 20678Communication Engine Modules: 20678ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DHTGA