Events

Field Safety Notices about Heater-Cooler Unit

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
    2016-08-22
  • 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
    Maquet cardiopulmonary as well as the national competent authorities in multiple countries have received reports confirming the presence of mycobacterial contamination (and other bacterial contamination) in the system water of heater and heater-cooler devices, mainly used during cardiothoracic surgeries to warm or cool a patient. although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.

Device

Heater-Cooler Unit

Manufacturer

Maquet Cardiopulmonary GmbH
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AMPMDRS