PERFUSION REPORTS

REPORT

100

DATE

20/4/2022

TITLE

Gas Line Filter Fault

DETAILS OF INCIDENT

On setting up for CPB and when testing the gas blender it was noted that there was an issue with the gas filter. This has happened with 2 filters out of 13 sets used with the same batch number.

The gas blender/ventilation module used was the Spectrum gas blender and when there is an occlusion of the gas line there is a visual representation of exclamation marks ie. !!!. Also the "Oxy-In" pressure readings were over 110mmHg which is outside the normal range and it causes a clicking sound in the ventilation module. This all occurred pre CPB before Diagnostics were switched on.

When Diagnostics are switched on there is a loud audible alarm and a flashing alert on the blender.

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DETAILS OF INJURY TO PATIENT

n/a

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TYPE OF DEVICE/MANUFACTURER

Liva Nova Gas Line Filter

ACTION TAKEN

The affected filters were switched out and replaced with a spare. The issue was rectified.

The filters were kept for return to manufacturer and a complaint filed.

Perfusion team were informed of the 2 faulty filters and must be vigilant when using the remaining sets from that batch.

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RESPONSE FROM MANUFACTURER

Waiting for response

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

Picture of Blender (Diagnostics Off)

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