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 Sorin.

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 086 03 17 001
  • Event Initiated Date
    2017-05-18
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11073
  • 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
    Heater-cooler devices known or suspected to be contaminated with m. chimaera, based on the facility’s testing program or other information known to the hospital, should be removed from the operating room or, if feasible, from service as soon as is practicable. we recommend contacting your livanova representative to assess cleaning options prior to further use. 2. for facilities who have devices that are not known to be contaminated with m. chimaera, we recommend the following actions: following the operating instructions for heater-cooler devices and specifically those relating to cleaning and disinfecting. we continue to believe that following these operating instructions is essential to mitigating the potential risk posed by using these non-sterile devices. b. if appropriate for your operating room, direct or channel the heater-cooler exhaust away from the patient, e.G., to the operating room exhaust vent per the field safety notice “cardiac surgery mycobacterium risks c. conducting water quality monitoring per the field safety notice “cardiac surgery mycobacterium risks. d. using new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device. be aware that device contamination also may occur from other sources such as environmental contamination or device contact with contaminated accessories.

Device

Sorin Group perfusion system – Heater-cooler 1T, Heater-cooler 3T and FlexTherm devices
  • Model / Serial
    Catalog number: 16-02-50, 16-02-80, 16-02-81, 16-02-82, 16-02-83, 16-02-85, 16-02-95, 16-70-00
  • Product Description
    Warming/Cooling Units, Patient
  • Manufacturer
    Sorin

Manufacturer

Sorin
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Manufacturers representative
    Arabian Trade House Est.
  • Source
    SFDA