Events

Rappel de Plum 360 Infusion Pump, with 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-2016-RN-01199-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-12
  • 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-2016-RN-01199-1
  • 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
    Hospira has identified an issue where the user interface (ui) does not update to reflect a calculated dose value. this only occurs when using a dosing unit in the mmol or units families. if the 1st digit entered in the rate or vtbi field results in a calculated dose that is less than the pump limit (0.001), the pump will dash out (“---“) the dose field & display the message ”minimum hard limit dose is 0.001 press [c] key to clear entry”. this is expected behaviour. if the calculated dose is above 0.001 the pump will display the correct dose value. the issue occurs when entering additional digits in the rate or vtbi fields. if the dose field is dashed out, the ui will not display the newly calculated dose when subsequent digits are entered. despite this, the dose value is calculated correctly; but the ui does not update to reflect the correct calculated dose value.This issue does not occur if the dose value is directly entered in the dose field as opposed to being calculated by the pump.
  • Action
    Hospira is providing users with work around instructions to follow as an interim measure. Users can enter the dose manually to over-ride the dash out. A software update will be implemented as a permanent correction.

Device

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

Manufacturer

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