Events

Field Safety Notices about Heater Unit HU 35

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Maquet Cardiopulmonary GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-11-22
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AMPMDRS