Device safety informationMHRA
Belzer UW® Cold Storage Solution safety warning over a malfunction
The MHRA is providing an update on defects previously identified with Belzer solutions for the preservation of donated organs. This DSI replaces advice in DSI/2023/005.
What to do now
Belzer UW® Cold Storage Solution and Belzer MPS® may stop working properly or fail during use.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. A device that fails at the wrong moment can delay treatment or cause injury.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2026/006). Quoted as issued.
Summary
The MHRA is providing an update on defects previously identified with Belzer solutions for the preservation of donated organs. This DSI replaces advice in DSI/2023/005.
The risk
Summary The MHRA is providing an update on defects previously identified with Belzer solutions. These included leakage and discolouration, resulting in fluid which was potentially contaminated and posed a risk of significant patient harm. This DSI replaces advice in DSI/2023/005 , which should no longer be followed. Corrective action has been taken by Carnamedica and Bridge to Life to resolve the issues identified and as a result the suspension to sales of the product has now been lifted. Healthcare professionals should follow the instructions detailed in this update when using these solutions during organ donation and transplantation procedures. For information and action by:
Advice for healthcare professionals
The MHRA is providing an update on defects previously identified with Belzer solutions. These included leakage and discolouration, resulting in fluid which was potentially contaminated and posed a risk of significant patient harm. This DSI replaces advice in DSI/2023/005 , which should no longer be followed. Corrective action has been taken by Carnamedica and Bridge to Life to resolve the issues identified and as a result the suspension to sales of the product has now been lifted. Healthcare professionals should follow the instructions detailed in this update when using these solutions during organ donation and transplantation procedures.
Transplant Unit Directors / Co-ordinators
Organ donation and transplantation governance leads
Healthcare professionals involved in organ retrieval, transfer and transplantation
Healthcare professionals and laboratory staff involved in the receipt, use and storage of tissue derived from organs for transplantation – for example, accessory vessels
Healthcare professionals and laboratory staff involved in cell isolation work as a function of islet and hepatocyte laboratories.
Medical Device Safety Officer to circulate this DSI to relevant departments.
In line with standard clinical processes, healthcare professionals should follow these normal routine steps when administering the product:
identification and reporting of defective products
prior to use, each bag should be visually inspected for:
Discolouration – the fluid should be clear and transparent to slightly yellow (no more than Y6 according to the colouration scale in the current edition of Eur. Ph.)
Particulate matter – hold up to a light source for this check to be effective
Advice for patients
The advice in this DSI is aimed at the healthcare team responsible for providing and monitoring organ transplantation.
If you have any concerns, contact the specialist team who is responsible for your care.
Open the MHRA notice
Questions
Why has Belzer UW® Cold Storage Solution and Belzer MPS® been recalled?
Belzer UW® Cold Storage Solution and Belzer MPS® may stop working properly or fail during use. A device that fails at the wrong moment can delay treatment or cause injury.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.