REPORT
046
DATE
July 2020
TITLE
Centrifugal Head Issue 3
DETAILS OF INCIDENT

On setting up and priming, the centrifugal head omitted a humming noise and when touched you could feel a high frequency vibration.

The head was replaced and the new head was okay. This omitted it being a hardware (drive unit) issue.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Liva Nova Revolution Centrifugal head

Lot/Batch No: 1912170013

ACTION TAKEN

Disposable replaced. Sent back to manufacturer and reported on internal QMS.

RESPONSE FROM MANUFACTURER

See attached

ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO
SUPPORTING DOCUMENT

OTHER PERFUSION REPORTS

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REPORT NO
049
DATE
August 2020
LIVA NOVA RESPONSE TO REPORTED CENTRIFUGAL HEAD ISSUE
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048
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August 2020
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REPORT NO
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REPORT NO
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DATE
July 2020
Centrifugal Head Issue 3
REPORT NO
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DATE
June 2020
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REPORT NO
044
DATE
Jan 2020
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REPORT NO
043
DATE
Feb 2020
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042
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REPORT NO
039
DATE
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REPORT NO
038
DATE
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