Events

Avis De Sécurité sur MultiFiltrate

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 Ag & Co..

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
    2013-11-09
  • Date de publication de l'événement
    2013-04-10
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    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 / 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
    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.