Events

Avis De Sécurité sur Concentrated hemodialysis solution AC-F

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Fresenius Medical Care Serbia.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2014-12-31
  • Date de publication de l'événement
    2015-01-09
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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