PERFUSION REPORTS

REPORT

057

DATE

1/6/2020

TITLE

Centrifugal Head Issue 2

DETAILS OF INCIDENT

During priming an audible noise was noted coming from the revolution centrifugal head. There were also vibrations noted noted arising in the tubing. The unit was changed out pre bypass as it was felt that it was not appropriate to continue with this particular unit. The replacement unit removed the audible noise and vibrations and there were no subsequent issues.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Liva Nova Revolution Centrifugal head

Lot/Batch No: 2002100168

ACTION TAKEN

Liva Nova were contacted and the unit was retained for further inspection. Liva Nova informed us that they did not require the unit for inspection as it was a known issue which they were in the process of rectifying.

Reported on hospital/department system.

RESPONSE FROM MANUFACTURER

See attached

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

Manufacturer Response re Centrifugal Head 045

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Centrifugal head issue 4

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