PERFUSION REPORTS

REPORT

138

DATE

20/4/2026

TITLE

Oxygenator Changeout

DETAILS OF INCIDENT

Oxygenator changeout performed during Type A Aortic Dissection repair due to high pre membrane pressure and low post membrane pressure - 300 mmHg difference. Fine going on bypass but 20 minutes in could no longer run at full flow and could only flow at 75% flow. Asked surgeon to cool to 22C so we could perform oxygenator changeout. Temperature and gas management were all okay. Changeout performed in under 2 mins went back to full flow to ensure new oxygenator was working and pressures were much better before then performing DHCA and antegrade cerebral perfusion & continuing with the operation. No harm occurred.

DETAILS OF INJURY TO PATIENT

No harm

TYPE OF DEVICE/MANUFACTURER

LivaNova Inspire 8 oxygenator. Product code IN00664. Lot/Batch No 2601150031. Date of manufacture 17/04/2026, Expiry date 14/01/2029.

ACTION TAKEN

Oxygenator changeout

RESPONSE FROM MANUFACTURER

ADDTIONAL INFORMATION

No issue was logged with the manufacturer as they believe it may have been a patient specific issue during initial cooling. Exact cause has not been established.

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

OTHER PERFUSION
REPORTS

Select and scroll to view chosen report

REPORT NO

110



31/1/23

DISPOSABLE FAULT

REPORT NO

109



19/1/23

Disposable issue

REPORT NO

108



3/1/23

Disposable issue: Oxygenator leak

REPORT NO

107



6/12/22

Hardware fault. Electronic gas Blender failure

REPORT NO

106



1/11/22

ECG Interference

REPORT NO

105



9/9/22

Issue with use of disposable

REPORT NO

104



13/6/22

Human Factors

REPORT NO

103



25/7/22

Human Factors

REPORT NO

102



7/7/22

Disposable issue

REPORT NO

101



6/4/21

Irregular blood flow/foreign looking substance in Oxygenator

REPORT NO

100



20/4/22

Gas Line Filter Fault

REPORT NO

099



20/4/22

Human Factors: BiVAD Error

REPORT NO

098



4/4/22

REPORT NO

097



19/3/22

Disposables Issue

REPORT NO

096



18/3/22

Bubbles Sensor Activation

REPORT NO

095



1/1/22

Protamine Administration

REPORT NO

094



1/11/21

Oxygenation failure upon commencement of CPB

REPORT NO

093



1/11/21

Detached bullet tip of sump-updated response Sep 2022

REPORT NO

092



1/10/21

Vapourizer Issue

REPORT NO

091



1/10/21

Oyxgenator Leak

REPORT NO

090



1/10/21

Breach of chemical cleaner

REPORT NO

089



1/9/21

Sechrist Gas Blender Sweep on ECMO

REPORT NO

088



1/9/21

Oxygenator High Pressure Events

REPORT NO

087



1/10/21

Leaking one way valve

REPORT NO

086



1/7/21

Electronic Gas Blender Fault

REPORT NO

085



1/2/21

Protamine Administration Issue

REPORT NO

084



1/6/21

Damaged roller pump lid

REPORT NO

083



1/6/21

IABP malfunction

REPORT NO

082



1/1/21

Accidental cardioplegia administration

REPORT NO

081



1/4/21

S5 Double Roller Pump incident

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