Events

Rappel de Bayer 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-2015-RN-01195-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-07
  • 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-2015-RN-01195-1
  • 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
    Bayer medical care inc. has identified that certain batches of the source administration sets (sas) used with the medrad intego pet infusion system may contain out-of-specification saline tubing and/or solvent occluding the radio pharmaceutical (rp) tubing.The inner diameter of the saline tubing is out-of-specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. the occluded sas tubing may impair the priming function and prompt an “rp prime failed. check sas and vial installation, then reprime.” error message. although unlikely, these situations may lead to procedure delay, false negative result due to incomplete dose, inaccurate dose reporting in the patient record, overdose of rp delivered and in rare situations additional radiation exposure for the operator.
  • Action
    The sponsor Imaxeon is advising the users to inspect stock and quarantine the affected units prior to their return to the sponsor. There may be a delay in replacing the affected stock due to limited new inventory. This action has been clsoed-out on 29/08/2016.

Device

Bayer Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System
  • Modèle / numéro de série
    Bayer Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System [Catalogue Number INT CSS]Multiple batch numbers affectedARTG Number: 154205
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

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