PERFUSION REPORTS

REPORT

060

DATE

1/8/2020

TITLE

Oxygenator Fibre Leak

DETAILS OF INCIDENT

Midway through cardiopulmonary bypass for AVR+CABGx3 surgery a leak was observed emanating from the bottom of an Affinity Fusion oxygenator through one of the vents of the gas exhaust. Closer inspection revealed that blood has penetrated through a focalised cluster of fibres on the gas phase side. No change in arterial line pressure, blood gas values, or patient haemodynamics was apparent before or after detection of the leak. There was also no evidence of additional leaks, air entrainment or haemolysis. The total blood volume leaking was <5mls.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Affinity Fusion Oxygenator-Medtronic

Lot/Batch No: 219357399

ACTION TAKEN

The severity of the leak was assessed and deemed to be slight. No effect on the function of the oxygenator was observed. Both the consultant anaesthetist and surgeon were informed of the leak. The patient was at 32 degrees centigrade with cross clamp on. It was decided to continue with the operation and wean from bypass at the earliest and safest stage of the operation. The option to continue with the bypass 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 bypass was terminated.

The appropriate agency was informed of the incident.

RESPONSE FROM MANUFACTURER

n/a

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

Leak Picture One

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Detached bullet tip of sump-updated response Sep 2022

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