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 Baxter Healthcare.

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 080 03 14 000
  • Event Initiated Date
    2014-03-18
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=5492
  • 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
    Baxter healthcare is implementing additional warning label. specific population using peritoneal dialysis therapy including neonates, infants, small children and any patient with significant heart or lung disease are more vulnerable to the negative effects of excessive retention of fluid in the peritoneal cavity that may be related to their dialysis therapy. the additional warning identifies symptoms related to unintended increased intraperitoneal volume (iipv) that may result in theses specific populations and provides specific instructions for the patient to follow if increased intraperitoneal volume (iipv) that is suspected.

Device

HomeChoice Automated Peritoneal Dialysis Systems, HomeChoice PRO Automated Peritoneal Dialysis Sy...
  • Model / Serial
    Product Nos.: 5C4471, 5C4471R, 5C8310, 5C8320, 5C8310R
  • Product Description
    Peritoneal Dialysis Units
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare
  • Manufacturer Parent Company (2017)
    Baxter International
  • Manufacturers representative
    Arabian Health Care Supply Co. (AHCSC), Riyadh (01) 4747444
  • Source
    SFDA