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 103 11 13 001
  • Event Initiated Date
    2013-11-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4796
  • 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 ag would like to inform you of important product information that is being sent to customers to describe homechoice 10.4 software initial drain logic as it relates to the comorbid condition of ascites. patients with ascites may have a large volum of fluid in their potential cavity. patients with ascites who drain relatively large volumes (e.G. > 5 liter) when undergoing a paracentesis procedure should receive an albumin infusion to mitigate against developing hypotension and potential compromise of their hemodynamic status.

Device

Cycler machine, HomeChoice 10.4
  • Model / Serial
    Product Code 5C8310, Product Name HomeChoice Pro APD system 115V Product Code 5C4474, Product Name HomeChoice APD system Product Code R5C8320, Product Name HomeChoice PRO APD System, 230V ..................................... Swissmedic update codes : Product Code : Product Name 5C4471 : HomeChoice APD System, 115V 5C4471R : HomeChoice APD System, 115V, Serviced 5C8310R : HomeChoice PRO APD System, 115V, Serviced T5C4441 : HomeChoice (Yume) APD System, 230V T5C8300 : HomeChoice PRO (Yume Plus) APD System, 230V
  • Product Description
    Automated Peritoneal Dialysis, HomeChoice Pro APD system.
  • Manufacturer
    Baxter Healthcare.

Manufacturer

Baxter Healthcare.