Events

Rappel de Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose 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-2012-RN-01039-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-10-11
  • 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-2012-RN-01039-1
  • 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
    The volume control knob located on the back of the infuser may not function as described in the system operating manual; the direction for loud and quiet may be reversed. the manual indicates a clockwise rotation of the knob decreases the volume, however on some devices the alarm volume increases when the knob is turned clockwise. while the device will continue to alarm with an audible tone of at least 50dba at the lowest level, inadvertently setting a low tone may result in an audible alarm that is more difficult to hear.
  • Action
    Hospira is providing work around instructions and will be updating the Instructions for Use (IFU).

Device

Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infus...
  • Modèle / numéro de série
    Plum A+ Pump Version 11.6 and Plum A+ Pump Version 13.4 Med Net ABG Driver (general purpose infusion pump)Plum A+ Pump Version 11.6Catalogue number 611239101Number on pump: 12391/11971Plum A+ Pump Version 13.4 Med Net ABG DriverCatalogue number: 612079201Number on pump 20792ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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