Events

Avis De Sécurité sur Heater Unit HU 35

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 Cardiopulmonary GmbH.

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
    2016-11-22
  • 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
    Our internal investigations have confirmed that the current published disinfection procedure of the hu 35 system’s water paths (in the instructions for use) does not adequately meet contemporary hygienic requirements and effectiveness against atypical mycobacteria. although the water in the hu 35 circuit does not come into direct contact with the patient, there is the unlikely, but potential risk that bacterial contaminated water could cause adverse health consequences to the patient, e.G. by transmission (insufficient hygiene) via clinical staff members while managing the extra corporeal life support. .

Device

Heater Unit HU 35

Manufacturer

Maquet Cardiopulmonary GmbH
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    AMPMDRS