PERFUSION REPORTS

REPORT

035

DATE

1/10/2017

TITLE

Medtronic Fusion Oxygenator Blood To Gas Leak

DETAILS OF INCIDENT

Five minutes into bypass it was noticed that there was a small leak of blood coming from the underside of Fusion Oxygenator. Upon inspection there was a small collection of bloody bubbles gathering in the bottom of the device.

A sample was taken for blood gas analysis, M4 blood gas monitor was showing no abnormalities in gaseous parameters, all blood parameters came back as normal from the blood analysis on the external machine.

The surgeon was informed and after initially deciding to do an oxygenator change-out on bypass, it was then decided to carry on with the remaining procedure.The surgeon and anaesthetist were informed that we couldn't be certain that there was no blood/water mixing occurring at this stage from a possible leak between the heater/cooler. The device was returned to the supplier.

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DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

N/A

ACTION TAKEN

N/A

RESPONSE FROM MANUFACTURER

N/A

ADDTIONAL INFORMATION

N/A

SUPPORTING VISUALS/VIDEO

N/A

SUPPORTING DOCUMENT

OTHER PERFUSION
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REPORT NO

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120

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

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108



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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

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REPORT NO

100



20/4/22

Gas Line Filter Fault

REPORT NO

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

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REPORT NO

098



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REPORT NO

097



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REPORT NO

096



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REPORT NO

095



1/1/22

Protamine Administration

REPORT NO

094



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Oxygenation failure upon commencement of CPB

REPORT NO

093



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Detached bullet tip of sump-updated response Sep 2022

Perfusion Report cards are shown in batches of 30 at any one time where available.

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