Events

Field Safety Notices about MultiFiltrate

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Fresenius Medical Care Ag & Co..

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
  • Date
    2013-11-09
  • Event Date Posted
    2013-04-10
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/10/04/vazno-obavestenje-o-medicinskom-sredstvu-multifiltrate-aparat-za-akutnu-hemodijalizu-serijski-broj-m20-070-1-%d0%bc20-127-1-%d0%bc28-352-1/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The manufacturer has observed a software bug when using the substitution bolus function during crrt treatment. in one case, the substitution bolus unplanned did not stop after 100ml. in the worst case, the start of the substitution bolus is not controlled and stopped automatically and continues until it is stopped manually by the user. this situation can lead to a serious burden on the patient of excessive fluid and consequently a serious deterioration of the health status or even death of the patient. the cause of the error was determined to be software version 5.2. until we have provided you with an upgraded version of our software, it is our strict recommendation not to use the replacement bolus function.

Device

MultiFiltrate

Manufacturer

Fresenius Medical Care Ag & Co.