Events

Field Safety Notices about Heater Cooler 1T and Heater Cooler 3T

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 SORIN GROUP DEUTSCHLAND 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
  • 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
    Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always according to our instructions for use. without vigilant performance of the maintenance procedures per the instructions for use, organisms can multiply in a heater cooler device and potentially form biofilm. the biofilm provides an opportunity for bacteria, including mycobacteria, to colonize within the device. there is a possibility that bacteria can become aerosolized when the heater cooler device is operated and serve as a source for contamination.

Device

Heater Cooler 1T and Heater Cooler 3T

Manufacturer

SORIN GROUP DEUTSCHLAND GMBH