Events

Rappel de Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infusers (general purpose infusion pump).4200 PCA Infuser; List Number 610F78201PCA and PCA with MedNet Software Infusers; List Number: 612070901

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-00936-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-09-28
  • 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-00936-1
  • 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 received reports overseas from customers related to the improper use of the slide clamp when the syringe (vial) was manipulated or when stopping infusion during delivery of fluids. users are being informed of the correct usage of the slide clamp and/or syringe manipulation to prevent over delivery.
  • Action
    Customers are being advised of the correct use of the c slide clamp and/or syringe manipulation to prevent over delivery.

Device

Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infuse...
  • Modèle / numéro de série
    Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infusers (general purpose infusion pump).4200 PCA Infuser; List Number 610F78201PCA and PCA with MedNet Software Infusers; List Number: 612070901ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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