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 165 07 13 002
  • Event Initiated Date
    2015-04-29
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=7560
  • 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
    Radiometer has become aware that some d788 pco2 membranes can cause biased measurement results on patient results as well as qc results. the bias can be seen after the replacement of the membrane, and will be positive in the low range and negative in the high range. there is a risk of wrong diagnosis and maltreatment of patients for biased measurement results in the high range , root cause investigation is still in progress, but the preliminary root cause is variations in the thickness of a silicone layer used in the membrane units. the error was discovered through internal testing on blood and qc material in connection with a capa raised to document the investigation of an issue regarding low qc comparison results. ....................... bfarm update action: your local radiometer representative has now installed the improved sealing ring for the ph electrode in your abl700 and abl800 series analyzers. the improved sealing ring may be identified by its blue color.

Device

Analyser, blood gas , pCO2 Membrane Box (D788), used on ABL700 and ABL800 series analysers
  • Model / Serial
    R338 to R493; part 942-063, pCO2, D788 Membrane ............................ Update code from MHRA: Select one of the Quality Control products listed below to be used for pCO2 verification: Qualicheck3+: S7330 (Level 1) Autocheck3+: S7335 (Level 1) Please see the attachment
  • Product Description
    Pco2 Membrane Box (D788), used on ABL700 and ABL800 series analysers
  • Manufacturer
    Radiometer Medical

Manufacturer

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