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 Healthcare.

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 062 06 14 001
  • Event Initiated Date
    2016-01-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8802
  • 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
    The manufacturer identified software related issues. detailed description on the issues is available in the attached letter. ........................ ncmdr update action : baxter is sending this communication to announce the release of abacus software version 3.2. baxter will be implementing abacus software version 3.2 at customer facilities as a correction to the issue communicated in our may 7, 2015 safety alert letter, regarding the possibility that the compounder will load the incorrect formula under conditions when two or more different formula files have been created with the same file name.

Device

ABACUS Total Parenteral Nutrition (TPN) Calculation Software
  • Model / Serial
    ABACUS Total Parenteral Nutrition (TPN) Calculation software Versions 2.0, 2.1, 3.0 and 3.1 (ABACUS). Product code: 8300-0046, 8300-0047
  • Product Description
    Information Systems, Data Management, Provider Order Entry
  • Manufacturer
    Baxter Healthcare

Manufacturer

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