A leak was observed emanating from the bottom of an Affinity Fusion oxygenator through two of the vents of the gas exhaust. The leak was observed during cardiopulmonary bypass a few minutes after cross clamp was applied for AVR surgery. Closer inspection revealed foamed blood widespread across the bottom of the oxygenator which was obscured the source of the leak. The leak was estimated to be approx 2-3mls/min. No change in arterial line pressure, blood gas values, or aptient haemodynamics was apparent before or after detection of the leak, or throughout the case that could be attributed to the leak. There was also no evidence of additional leaks, air entrainment or haemolysis.
None
Medtronic Fusion Oxygenator-custom circuit.
Date of manufacture: Sep 2021
Both the consultant anaesthetist and surgeon were informed of the leak. Based on this experience and the assessment of the severity of the leak it was decided to continue with the operation and wean from bypass at the earliest and safest stage of the operation. The decision to continue bypass rather than perform an oxygenator changeout was deemed to have the least risk based on the nature of the leak i.e. minimal blood loss, leak from blood to gas phase. Regular monitoring of the leak was performed until the bypass was terminated. No effect on the function of the oxygenator was observed.
Awaiting response
Appropriate agency informed