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 Radiometer Medical.

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 001 02 11 000
  • Event Initiated Date
    2011-02-01
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=102
  • 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
    (in january 27 , 2011 ) sensor cassette 946-008 lot r0031 has been found to exceed specifications for the parameters ph, k, na, ca and cl. the error resembles a positive bias on the reference electrode, increasing in size from installation of the cassette. the resulting parameter bias is of the order of 9 mmol for sodium, 0,1 mmol for calcium, 0,2 mmol for potassium, -0,018 for ph and -7 mmol for chloride. two incidents regarding lot r0031 were reported from the field, one from belgium (radiometer ref. rbnl 576990103) and one from finland (radiometer ref. trio 579829752). no reports of death or serious injury were received, but the chemist at the finnish hospital suspects that patients could have been maltreated. the clinical risk assessment of the belgian incident states that the error could lead to clinical serious misinterpretation and mal-therapy in the critical care setting if it should happen again.

Device

Blood Gas Analyzers - ABL90 FLEX
  • Model / Serial
    ABL90 FLEX and accessory SC90 946-008 sensor cassette Software version: 2.4.1680.25 Lot/batch no.: R0031
  • Product Description
    Metabolic profile clinical chemistry analyser IVD, stationary, automated
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Manufacturers representative
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA