Events

Avis De Sécurité sur Heater/Cooler Systems

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 MAQUET.

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
    2015-11-30
  • 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
    Maquet cardiopulmonary as well as the national competent authorities in multiple countries have received reports confirming the presence of mycobacterial contamination (and other bacterial contaminants) in the system water of heater and heater/cooler devices. this system water is used in the direct patient warming and or in heat exchangers used to warm the patient blood during surgical procedures (cardiac bypass procedures). maquet cardiopulmonary has confirmed that maquet systems used in these procedures are contaminated with various strains of bacteria that also include mycobacteria species. the exact source of this contamination is unknown.

Device

Heater/Cooler Systems
  • Modèle / numéro de série
  • Manufacturer
    MAQUET

Manufacturer

MAQUET
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    AMPMDRS