MHRA Update: Haemodialysis and Haemofiltration Machines (ICN 1820)
Important Customer Notice Field Safety Notice
Ref: 2022/1820
ICN Number: 1820
MHRA DSI/2022/004
NHS Supply Chain Reference: 49
Alert:
- The Medicines and Healthcare products Regulatory Agency has issued a product safety information update dated 22 September 2022 affecting all models and makes of haemodialysis and haemofiltration machines.
- Venous and arterial pressure limits may be altered unintentionally following acknowledgement of the alarm in some haemodialysis and haemofiltration machines. If the cause of the alarm is not addressed, the machine may not re-alarm to alert the user to an ongoing problem.
Products Affected:
- All makes and models of haemodialysis and haemofiltration machines.
Next Steps:
- See our Useful Links section to read and follow the full instructions in the MHRA’s update and share with all users of the affected products.
- If you have any questions about the medical content in this update, contact MHRA at info@mhra.gov.uk.