Events

Rappel de All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pumps with MedNet Software

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-00188-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-27
  • 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-00188-1
  • 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 distal pressure sensor calibration may have drifted and require re-calibration. the following error codes may be displayed during set up or infusion on the affected devices: e180/n180, e181/n181, e186/n186, e187/n187, e346. if distal pressure sensor drift occurs, the pump may not sense the build up of pressure and will not alarm when occlusion thresholds are exceeded.
  • Action
    Hospira is providing end users with instructions to determine if they are affected by the issue. Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Hospira is also in the process of evaluating the design of the distal pressure sensor to reduce the opportunity for pressure sensor drift. Additionally, a yearly test to determine if the distal pressure sensor’s calibration has drifted will be released in 2013.

Device

All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pum...
  • Modèle / numéro de série
    All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pumps with MedNet SoftwarePlum A+Single Channel Infusion PumpCatalogue Number: 611239101Number on Pump: 12391 & 11971Plum A+ Infusion Pump with MedNet SoftwareCatalogue Number: 612079201Number on Pump: 20792Plum A+3 Infusion Pump with MedNet SoftwareCatalogue Number: 612067801Number on Pump: 20678
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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