Events

Field Safety Notices about Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Fresenius Kabi Limited.

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(08)
  • Date
    2014-02-27
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/applix-smart-applix-vision-nutrition-pumps-serial-numbers-from-1998xxxx-to-2010xxx&id=dd77f825-9782-6eee-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
    Fresenius kabi received an increasing number of complaints from the market about non-detected occlusions. as one possible influencing factor, a defective ball bearing was identified, potentially leading to a shift in the flow rate calibration values. fresenius kabi has been unable to locate all affected pumps that require an upgrade.
  • Action
    The IMB advises that users:  (1) The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation, including those who maintain pumps and to any other persons/organisations where these devices have been transferred.  (2) Identify the location of all affected pumps.  (3) If you / your institution have any affected pumps, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and contact Fresenius Kabi.

Device

Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx
  • Model / Serial
  • Product Description
    Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx
  • Manufacturer
    Fresenius Kabi Limited

Manufacturer

Fresenius Kabi Limited