Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Baxter Corp Canada.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 054 06 17 000
  • Event Initiated Date
    2017-06-15
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11184
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    After a planned sharesource outage on may 28, 2017, three issues occurred: - the patient consent to share data was required, even though there was no revision of the patient consent content. a failure to submit a patient consent through the claria cycler resulted in patients being prompted to enter the patient activation code (pac) before each treatment, and no treatment data from the claria is shared with the clinic. - clinicians saw incorrect message “not for human use” on sharesource website. - some reviewed treatment history was not visible; those treatments were no longer marked as “reviewed”.

Device

Sharesource Claria Connectivity Platform for Use with Homechoice Claria APD System
  • Model / Serial
    Product Code# 5CGM01
  • Product Description
    home dialysis therapy
  • Manufacturer
    Baxter Corp Canada

Manufacturer

Baxter Corp Canada
  • Manufacturer Parent Company (2017)
    Baxter International
  • Manufacturers representative
    Arabian Health Care Supply Co. (AHCSC) Riyadh (01) 4747444
  • Source
    SFDA