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 Terumo Cardiovascular Systems Corporation.

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 154 07 18 000
  • Event Initiated Date
    2018-07-31
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12995
  • 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
    Specific subset of the h/sat probe assembly population is being withdrawn due to a supplied component in the optics, the optical module. a change by the supplier to a different material and anodization resulted in increased failures. h/sat probe assemblies are used in production and in service. the cdi system 500 monitor conducts an automated self-test when the device is powered on. if the monitor contains an affected component, a color chip test failure will occur and the h/sat probe will be disabled.

Device

CDI Blood Parameter Monitoring System 500 H/Sat Probe Assembly
  • Model / Serial
    HSat Probe Assembly, CDI 500 : 145883 Monitor with one Blood Parameter Module and one HSat Probe : 500AHCT Monitor with two Blood Parameter Modules and one HSat Probe : 500AVHCT
  • Product Description
    Continuous bloodparameter monitoringfor improved bloodgas management
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA