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 Gambro..

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 034 01 11 000
  • Event Initiated Date
    2011-01-17
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=49
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The patient / priming detector is integrated in the venous clamp. if the start up procedures for on-line priming described in the operator's manual are not followed when preparing the ak 200 ultras and ak 200 ultra machines for a patient treatment, a significant safety feature may be compromised, in which case the device may not be able to detect blood. this issue may arise if the operator: -fails to properly attach the venous line in the venous clamp during the priming procedure; and -fails to verify the illumination of the machine blood path indication after patient connection; and -fails to confirm start of treatment; and - ignores the audible alarm and attention related to the achieved extra priming volume.

Device

HAEMODIALYSIS SYSTEMS.
  • Model / Serial
    AK 200 ULTRA S with software 9.20 or older AK 200 ULTRA with software 8.00 or older
  • Product Description
    HAEMODIALYSIS.
  • Manufacturer
    Gambro.

Manufacturer

Gambro.
  • Manufacturer Parent Company (2017)
    Baxter International
  • Manufacturers representative
    Arabian Medical Marketing Co. (AMCO), Riyadh, (01) (01) 4887122
  • Source
    SFDA