MHRA Safety Alert – Hemodialysis

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: EnglandScotlandNorthern IrelandWales. 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:

https://www.gov.uk/drug-device-alerts/dialog-haemodialysis-machines-with-software-versions-9-xx-excluding-versions-9-18-9-1a-9-1b-software-and-hardware-upgrade-required-mda-2019-024

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

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