Events

Field Safety Notices about Concentrated hemodialysis solution AC-F

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 Serbia.

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
    2014-12-31
  • Event Date Posted
    2015-01-09
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2015/01/09/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-ac-f-model-2194-koncentrovani-rastvor-za-hemodijalizu-kiseli-broj-sarze-bfb12200/
  • 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
    Using ac-f 219/4 acid concentrated hemodialysis solution, batch number vfv12200, patients with chronic hemodialysis program manifested clinical symptoms of systemic hypocalcemia in a larger number of patients in 5 dialysis centers in serbia. the symptoms were as follows: cardiovascular collapse of patients, a sudden drop in tension, general poor condition of patients, spasms, tingling sensation, change in taste in the mouth ... an adverse reaction to the medical device occurred due to an error in one of the phases of production of the said batch so that the delivered medical device had a lower concentration of calcium ions than declared. the condition of chronic systemic hypocalcemia can lead to further unexpected serious deterioration of patients' health or even death.

Device

Concentrated hemodialysis solution AC-F

Manufacturer

Fresenius Medical Care Serbia