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 Medtronic.

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 045 02 18 000
  • Event Initiated Date
    2018-02-13
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12121
  • 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
    In recent years, safety issues have been raised by regulators, including fda, regarding water system quality of temperature controllers, regardless of the manufacturer. the concern stems from the potential for bacterial growth in the water systems that can be transmitted to patients during surgery, and is likely related to the recommended water system cleaning practices and protocols employed. medtronic distributed bio-cal devices to the marketplace between 1989 and 2011. as of january 31, 2018, there have been two complaints received that suggest patients acquired a serious infection while undergoing surgery when a bio-cal device was being utilized. these complaints were received from a single customer in 2015. although a direct causal connection between the patient infection and the bio-cal could not be confirmed, the infection type was consistent with a waterborne bacterium (mycobacterium abcessus) and could have been attributed to the site’s cleaning and disinfecting of the device prior to use.

Device

Bio-Cal Temperature Controller
  • Model / Serial
    Model Number 370 and 370I
  • Product Description
    Heart-lung bypass system module, temperature control unit
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Manufacturers representative
    Medtronic Saudi Arabia
  • Source
    SFDA