Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Imaxeon Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01195-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01195-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DHTGA