Events

Field Safety Notices about HomeChoice/HomeChoice PRO Automated PD System

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Baxter Healthcare SA.

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
    Field Safety Notice
  • Event Number
    SN2014(11)
  • Date
    2014-03-14
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/homechoice-homechoice-pro-automated-pd-system&id=baccf925-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    Baxter healthcare is issuing a field safety notice (fsn) to inform users of the homechoice/homechoice pro systems of an additional warning to be included in the device product labeling. the warning relates to unintended increased intraperitoneal volume (iipv) in specific patient populations using peritoneal dialysis therapy.
  • Action
    1. Follow the manufacturer’s recommendations in the attached FSN. A copy of the FSN (and warning instructions) should be kept with your HomeChoice user manual. 2. Ensure that relevant personnel, in particular home patients, receive a copy of the attached FSN and are made aware of the information contained in the FSN and additional warning instructions.  3. If you have distributed the devices to other healthcare professionals or organisations, please forward this notice accordingly.

Device

HomeChoice/HomeChoice PRO Automated PD System

Manufacturer

Baxter Healthcare SA