Events

Rappel de Plum 360 Infusion Pump, software version 15.02

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-2017-RN-00001-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-05
  • 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-2017-RN-00001-1
  • 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
    Two software issues have been identified with the plum 360 infusion pump, software version 15.02, namely:issue 1 - the pump software incorrectly generates a “depleted battery” alarm instead of a “replace battery” alarm when the battery has a near end of life charge capacity. the expected performance of the infusion pump and software is for the infusion pump to generate a “replace battery” alarm when the software has determined the battery has reached a near end of life charge capacity. issue 2 – when ac power is lost and quickly resumed, the pump software incorrectly classifies the event as an e323 alarm condition. this result in an interruption of any ongoing therapy and the infusion pump will restart (reboot).
  • Action
    Hospira is advising users to connect the infusion pump to AC power and turn the pump on. They are requested to replace the battery if they see the “Replace Battery: Keep Plugged into AC! Service battery / replace pump” message. Users are also requested to replace the battery if they see the “Depleted Battery! Plug into AC now!” message while the pump is in operation. For battery replacement, users are requested to either send it to their in-house engineering department in the first instance and if further assistance is required, to contact the Hospira Service Centre.

Device

Plum 360 Infusion Pump, software version 15.02
  • Modèle / numéro de série
    Plum 360 Infusion Pump, software version 15.02List Number: 30010ARTG Number: 234421
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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