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 BCT Inc..

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 022 05 18 000
  • Event Initiated Date
    2018-05-07
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12573
  • 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
    Terumo states that if a blood warmer is attached to the tubing set of the above apheresis systems and the blood warmer is not primed before use, air could be delivered to a patient. the firm is reinforcing actions required to mitigate this risk. terumo states that many spectra optia procedures include the option to use a blood warmer. the spectra optia operator's manual instructs operators how to connect and prime a blood warmer when one is used. the operator's manual also includes warnings about the risk of delivering air to a patient if a blood warmer is not primed. further details are provided in attached letter.

Device

Spectra Optia Apheresis Systems
  • Model / Serial
    Apheresis Systems Spectra Optia 61000
  • Product Description
    Apheresis Units, Blood Donor, Plasma , Therapeutic, Platelet/Plasma Exchange , White Blood Cell
  • Manufacturer
    Terumo BCT Inc.

Manufacturer

Terumo BCT Inc.
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA