Events

Avis De Sécurité sur Dialyzer

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Asahi Kasei Medical CO., Ltd.

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
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    The investigation results showed that there were small breakages on hollow fibers in the returned dialyzers, which caused blood leakage during the dialysis treatment with hemodiafiltration (hdf) mode. note that these leakages occurred later than one hour after start of treatment, which means that such broken hollow fibers would not have existed at the beginning of the treatment. further internal investigation suggested that the broken hollow fibers were originated by the weakness of the hollow fibers to the pressure strength in a small restricted portion.

Device

Dialyzer

Manufacturer

Asahi Kasei Medical CO., Ltd