Events

Rappel de Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapphire infusion pump)

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-2014-RN-01126-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-17
  • 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-2014-RN-01126-1
  • 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
    Qcore medical, the manufacturer of sapphire administration iv set ap424 has become aware of an increased incidence in specific batches of sets leaking in the sleeve areas (the adapter that connects between the tube and other components). the infusion set leaks may potentially result in under-dose or allergic reaction (in case the set is leaking and the drug comes into contact with the patient or healthcare professional) or increased risk of infection. the likelihood of harm will depend on the patient’s circumstances, such as the severity of their illness, the healthcare setting and the criticality of the infusion. qcore medical is not aware of any report of injury attributed to this defect.
  • Action
    Hospira is requesting the users to check the AP24 set for leaks at the start of administration and to follow the instructions for use included with the Administration Sets and with the Sapphire Infusion Pump. New sets, without the defect should be available in mid November. This action has been closed-out on 01/03/2016.

Device

Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapph...
  • Modèle / numéro de série
    Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapphire infusion pump)Catalogue Number: 611637201Product reference: 12003-000-0015List Number: 16372A9601Batch Numbers: 0167000814, 0167001414, 0167001514, 0167001914 and 0167002414ARTG Number: 200689
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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