REPORT
048
DATE
August 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

OTHER PERFUSION REPORTS

London Core Review Cardiothoracic Surgery Course - Touch icon
London Core Review Cardiothoracic Surgery Course - Help Guide
Select and scroll to view chosen report
REPORT NO
049
DATE
August 2020
LIVA NOVA RESPONSE TO REPORTED CENTRIFUGAL HEAD ISSUE
REPORT NO
048
DATE
August 2020
Oxygenator Fibre Leak
REPORT NO
047
DATE
May 2020
Failure to remove CO2 effectively
REPORT NO
046
DATE
July 2020
Centrifugal Head Issue 3
REPORT NO
045
DATE
June 2020
Centrifugal Head Issue 2
REPORT NO
044
DATE
Jan 2020
Centrifugal Head Issue
REPORT NO
043
DATE
Feb 2020
Faulty Pressure Relief Valves
REPORT NO
042
DATE
Apr 2020
Leaking ALF
REPORT NO
041
DATE
Feb 2020
Arterial Line Filter Leak
REPORT NO
040
DATE
Mar 2019
Gas Line Filter Issue
REPORT NO
039
DATE
Dec 2019
Dual Lumen Cannula Movement
REPORT NO
038
DATE
Oct 2019
Venous Cannula Damaged
BACK TO SAFETY ARCHIVE