Events

Field Safety Notices about Dialyzer

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 Asahi Kasei Medical CO., Ltd.

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
    The investigation results showed that there were small breakages on hollow fibers in the returned dialyzers, which caused blood leakage during the dialysis treatment with hemodiafiltration (hdf) mode. note that these leakages occurred later than one hour after start of treatment, which means that such broken hollow fibers would not have existed at the beginning of the treatment. further internal investigation suggested that the broken hollow fibers were originated by the weakness of the hollow fibers to the pressure strength in a small restricted portion.

Device

Dialyzer

Manufacturer

Asahi Kasei Medical CO., Ltd