Events

Rappel de Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps and to charge a GemStar battery pack)

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-2013-RN-01251-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-02
  • 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-2013-RN-01251-1
  • 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
    1. when the docking station is used in conjunction with a gemstar phase 3 pump (list 13000-xx, 13100-xx or 13150-xx), the potential exists for the pump to fail to power up while connected to the docking station.2. the second situation arises when either a gemstar phase 3 (list 13000-xx, 13100-xx or 13150-xx) or gemstar phase 4 pump (list 13086-xx, 13087-xx or 13088-x) is used in conjunction with both a docking station and an external battery pack accessory (list 13073-xx). with this configuration, there exists a possibility that the gemstar pump will display error code 11/003 indicating excessive input voltage from the external sources. the 11/003 error code will stop infusion if the error occurs when an infusion is in process.
  • Action
    Hospira is providing work around instructions to mitigate the issues. if the device fails to power up end users are advised to remove the pump from the Docking Station and then power on the pump using 2 fresh AA batteries. To mitigate the 11/003 Error Code, end users must remove the battery pack prior to installing the pump on the docking station. If users are using a docking station in conjunction with an external battery pack accessory (List 13073), Hospira is advising that this practice should not continue. Users are advised to contact Hospira to discuss an appropriate alternative option.

Device

Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps and to ...
  • Modèle / numéro de série
    Gemstar Docking Station (Used as an alternate power source for the GemStar infusion pumps and to charge a GemStar battery pack)List Number: 13075-XX-07 and 13075-XX-09ARTG Number: 138118
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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