Events

Rappel de Source Administration Sets (SAS) used with the Medrad Intego PET 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 Imaxeon Pty Ltd.

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-2016-RN-01498-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-11-16
  • 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-2016-RN-01498-1
  • 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.
  • Notes supplémentaires dans les données
  • Cause
    Imaxeon have determined that all current source administration sets (sas) used with the medrad intego pet infusion system may produce particulates in radiopharmaceutical (rp) vials when the needle is inserted. these particulates may be generated when the tip of the needle pushes through the rubber septum of the vial. this presents a potential safety risk of particulate(s) being injected into a patient. to date, there have been no reports of patient or user injury.
  • Action
    Imaxeon is advising customers to immediately discontinue use of the Intego system and quarantine the SAS disposable units that they have in stock. They are also advised to determine an alternative method of the radiopharmaceutical delivery such as manual injections, if feasible. Imaxeon is in the process of qualifying a compatible in-line filter to be used with the SAS and will advise customers of the results in the next few weeks. Due to the limited inventory, customers may retain their quarantined units to be later used with the in-line filters. Alternatively, customers may return their units back to Imaxeon for a credit.

Device

Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System

Manufacturer

Imaxeon Pty Ltd
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    DHTGA