During a 3 day period this unit experienced 2 incidents of abnormally high trans-membrane pressure gradients (TMP) during the early stages of cardiopulmonary bypass. The department routinely utilises roller pumps for bypass and measures pre- and post-membrane pressures for all cases. Abnormal gradients are defined within the unit as P >300mmHg, with attention to related factors e.g. flow etc. Consideration for oxygenator change out is only made when perfusion becomes limited and potentially inadequate. For the cases there were no observed common factors e.g. surgeon or perfusion scientist; however the same oxygenator model (Sorin Inspire 6F) was utilised but each had a different batch number.
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In both cases the oxygenators were preserved and returned to the manufacturer for analysis.
The findings are outlined below: DHR verification did not reveal any relevant information possibly linked with the claimed event. Significant haematic deposits were found in both oxygenator and heat exchanger fibre mats. This is classified as a rare event, with a 0.03% global complaint rate in 2015. Most likely the root cause of the issue is multi-factorial, where a combination of triggering factors might be originating the phenomena including interaction with clinical procedure and patient. A number of activities are on-going to identify the possible root causes of the issue Internal R&D, QA and marketing resources together with Consultants from national and international Universities are working on the matter.
The department has reviewed its protocols for dealing with these cases after an extensive review of the relevant literature; however each case needs to be assessed relative to its immediate situation. The decision whether to change out an oxygenator lies with the case perfusion scientist following discussion with the Consultant Surgeon and Anaesthetist.
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