Freedom of Information request on Medtronic Affinity Fusion oxygenator (FOI 21/773)
Published 29 December 2021
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29th July 2021
FOI 21/773
Dear
Thank you for your information request, dated 5 July 2021 where you asked the following:
I am trying to find out if anyone else has reported issues recently with high pressure excursions and/or oxygenator failure using the Medtronic Affinity Fusion oxygenator for cardiopulmonary bypass. We have had two such issues in the past two months and are attempting to determine whether it is safe to continue using this device. Are you able to provide me with this information please?
With regards to the overall investigation we are liaising with the company as part of this investigation. Once we receive further information from them, we can then contact you to provide a formal update.
You may wish to contact the MDSO for your site to consider utilising the MDSO forum to contact other NHS Trusts to find out if they’ve had similar problems.
In the meantime, if you receive any additional information regarding this issue that you wish to discuss, please contact myself directly via the details below.
Many thanks for contacting the MHRA and for bringing this issue to our attention.
Yours sincerely
Senior Medical Device Specialist
Devices Safety and Surveillance Group