Events

Rappel de All GEMSTAR Family of Infusers; GemStar Infusion System - Single Therapy; GemStar 7 Therapy 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-2013-RN-00247-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-12
  • 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-2013-RN-00247-1
  • 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
    The proximal and distal pressure sensor calibration can drift resulting in late or missed or false occlusion alarms or reporting of one of the following errors during device setup or infusion:- cassette check – d- cassette check – p- proximal occlusion- distal occlusion- pressure calibration error- bad pressure sensor event- bad pressure sensor state- distal pressure is out of range- proximal sensor is out of range.
  • Action
    Hospira recommends customers to review the GemStar maintenance schedule and confirm that the Operation test (which includes specific tests for proximal and distal occlusion) is being performed at least on an annual basis. If a device fails either of the proximal or distal occlusion tests at any time immediately remove it from clinical service and return it to and return it to Hospira for repair. Hospira is in consultation with TGA for any further action. Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which delay/interruption in therapy or under/over infusion could result in significant injury or death.

Device

All GEMSTAR Family of Infusers; GemStar Infusion System - Single Therapy; GemStar 7 Therapy Infus...
  • Modèle / numéro de série
    All GEMSTAR Family of Infusers; GemStar Infusion System - Single Therapy; GemStar 7 Therapy Infusion SystemGemStar Infusion System - Single TherapyCatalogue Number: 611308801Number on Pump: 13088 / 13150GemStar 7 Therapy Infusion SystemCatalogue Number: 611308701Number on Pump: 13087 / 13000
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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