Events

Rappel de Hospira Plum 360 Infusion System

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-00729-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-06-23
  • 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-00729-1
  • 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
    Icu medical has identified a potential for the connectivity engine (ce) module to disengage from the main chassis. in a rare situation, this could lead the plum 360 infuser to power down without an alarm notification resulting in a delay of either initiation of a therapy or interruption of an active infusion. in rare circumstances, these conditions could lead to serious adverse health consequences related to life threatening or permanent injury, which may include death.To date, icu medical has not received any reports of serious injury or death associated with this issue.
  • Action
    ICU Medical will be contacting users and arranging for inspection of all affected Plum 360 infusers. The chassis will be replaced as required. In the interim, ICU Medical is advising users to inspect the affected Plum 360 Infusers using the instructions provided in the customer letter in order to verify that the infuser is working. If at the end of testing a loose CE module or blank display is observed, the infuser is to be removed from service, and the user is to record the S/N and contact the ICU Service Department. Otherwise, the infuser can be returned to clinical use. If the Plum 360 Infuser powers down without an alarm notification during infusion, use another Plum 360 Infuser for infusion or consider use of alternative infusion methods based on the clinical situation.

Device

Hospira Plum 360 Infusion System

Manufacturer

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