Events

Field Safety Notices about Heater-Cooler Units HCU 20 and HCU 30

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.

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
    2017-10-26
  • 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
    The maquet heater-cooler units hcu 20 and hcu 30 are used for cooling or warming a patient connected to an extracorporeal perfusion circuit and keeping the required patient temperature constant. the thermal transfer occurs via a heat exchanger in the patient perfusion circuit and/or cardioplegia water circuit and/or via a warming/ cooling blanket. there is no contact between the patient’s blood stream and the system water circulating through the heat exchanger. .

Device

Heater-Cooler Units HCU 20 and HCU 30
  • Model / Serial
  • Manufacturer
    Maquet

Manufacturer

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