Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required (MDA/2019/024)
Summary
Manufactured by B. Braun Avitum AG – Malfunction of the temperature sensor can result in temperature of the dialysis fluid to be more than ±1°C outside the programmed values, which can lead to inadequate treatment.
Action
- Identify affected machines
- Contact the manufacturer to obtain service kit SW 9.1B or to schedule machines for a service upgrade.
- Ensure this upgrade is scheduled at the next planned service, prioritising patients who use this machine at home.
- Whilst waiting for the scheduled upgrade:
- be aware of the potential for incorrect dialysis fluid temperatures whilst patients are undergoing treatment. The machine will alarm and stop treatment if the temperature goes outside the range 33 to 42 °C.
- consider adding a check for dialysis fluid temperature if a patient complains about unexpectedly feeling warmer or cooler than usual during treatment.
- Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
Action by
All staff responsible for using and maintaining haemodialysis equipment.
Deadlines for actions
Actions underway: 18 September 2019
Actions complete: 26 June 2020
Problem/background
It has been identified that if the temperature sensor at the dialyser inlet (TDSE) experiences a malfunction, the Dialog+ machine may try to incorrectly heat or cool the dialysis fluid anywhere between 33 and 42°C.
The machine will continue to operate but will not alarm to indicate that the temperature of the dialysis fluid is ±1˚C outside its prescribed value. Implementing the service kit SW9.1B will resolve this issue.
If the temperature of the dialysis fluid falls below 33°C or exceeds 41°C at the temperature sensor in the machine, treatment will stop and the machine will alarm.
Device details
This issue affects all Dialog+ machines with software versions 9.xx (excluding software 9.18, 9.1A, 9.1B). The current software version of your machines can be identified from the start screen in the lower right corner, after you switch on the machine.
The dialysis fluid temperature can be accessed via a service screen for comprehensive review by a trained service technician.
Manufacturer contacts
Product Complaints – B. Braun Medical UK
Tel: 0114 2259155
Email: catherine.clulow@bbraun.com
Business Manager – B. Braun Avitum UK
Tel: 0114 2259000
Email: christine.mccabe@bbraun.com
B. Braun Avitum UK will contact customers directly to provide additional information.
Link to MHRA site:
