Events

Rappel de PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers

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-01288-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-10
  • 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-01288-1
  • 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 door roller assembly on the plum a lifecare 5000 series and plum xl has the potential to break which can lead to possible unrestricted flow and/or over delivery during the removal of the iv administration set's cassette from the pump.
  • Action
    Hospira is requesting hospitals to take the following steps to inspect the door assemble prior to loading the cassette: -Open the cassette door by pulling on the lever - Unlatch the cassette door by pushing on the door release tab and pulling the door down. -Visually inspect the door roller pin for any evidence of the damage or door roller misalignment. -Ensure that the door roller spins smoothly with a finger touch. If any door rollers or pins appear losse, broken or missing, Hospira is advising to remove the device from use. Hospira is in the process of retiring the Plum LifeCare 5000 and Plum XL in 2015.

Device

PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers
  • Modèle / numéro de série
    PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers Plum LifeCare 5000List Number: 02507Plum XLList Number: 11555Plum XLMList Number: 11846Plum XLDList Number: 11859ARTG Number: 138109
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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