Safety Alert Or Field Safety Notices for Fresenius 5008 & 5008S haemodialysis machines

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.

MHRA has been made aware of the risk of inadequate fluid removal during treatment due to the failure of the ultrafiltration (UF) pump, which cannot be identified during the manufacturer’s technical safety checks. This failure can happen suddenly, without the machine alarming, and currently can only be identified by observing incomplete fluid removal from patients after dialysis treatments.