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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

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

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

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

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

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

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

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REPORT NO

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

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

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

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

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

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

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

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

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

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

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