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 Codan Argus AG.

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 057 05 14 000
  • Event Initiated Date
    2014-05-13
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=5823
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The basis of this field safety notice are pertaining to the frequent technical errors #8123 and #8129 on codan argus 717v infusion pumps. technical errors #8123 and #8129 originate from the self-test of the down-stream pressure sensor. analysis by the manufacturer revealed that apart from broken pressure sensors, excessive hardness of the intravenous infusion set could trigger these technical errors. the technical errors occur once the intravenous infusion set is inserted and the user closes the pump door - before the infusion is started. any such delay of infusion or interruption of therapy through a false infusion pump alarm, which may potentially put the patient’s health at risk, is unacceptable. unanticipated variations of the mechanical properties of the intravenous infusion sets were identified as the root cause of above mentioned false technical errors.

Device

Infusion pump CODAN ARGUS 717/718V
  • Model / Serial
    Control software version 5.05
  • Product Description
    Infusion pump, multifunction
  • Manufacturer
    Codan Argus AG

Manufacturer

Codan Argus AG
  • Manufacturer Parent Company (2017)
    Codan Argus Ag
  • Manufacturers representative
    Al-Jeel Medical & Trading Co. LTD, Riyadh (011) 4041717
  • Source
    SFDA