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 Gambro Lundia AB.

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 039 11 16 000
  • Event Initiated Date
    2016-11-06
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10188
  • 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
    Baxter ag is issuing a voluntary urgent device correction for ak 98 dialysis machines due to two software issues. : i. the machine could become stuck in a fluid by-pass state if the operator confirms the air detector alarm during priming. in a fluid bypass state, the fluid path bypasses the dialyzer and no ultrafiltration (uf) or diffusion occurs, leading to an absence of treatment. ii. the ultrafiltration supervision (ufs) may be put in an idle (non-functional) state, if the functional check of the blood module is delayed and is completed after the functional check of the fluid module.

Device

AK 98, 230V, Bio
  • Model / Serial
    Product Name: AK 98, 230V, Bio Product Code: 115248 Serial Numbers: All (please refer to attached affected customers list).
  • Product Description
    Dialysis machine
  • Manufacturer
    Gambro Lundia AB

Manufacturer

Gambro Lundia AB