REPORT
044
DATE
Jan 2020
TITLE
Centrifugal Head Issue
DETAILS OF INCIDENT

Two Liva Nova centrifugal head disposables that were noticed to make an unusual sound during priming. The first one (07/01/2020) was observed to wobble (video footage sent to company). The second disposable (24/01/2020) was not noticed to wobble but there was an audible hum that replacement with a new centrifugal head removed. In both cases the issue was noticed during priming and the disposable was able to produce flow but the suspected flaw was felt to be potentially dangerous.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Liva Nova Revolution Centrifugal Head

Product Code: AB1579

Lot/Batch No: 1902150167/1908020195

ACTION TAKEN

Replacment of centrifugal heads in both instances during priming removed sound and wobble. Company contacted after initial disposable failure and collection for assessment arranged. Second disposable error prompted safety report due to repeat quality issue.

RESPONSE FROM MANUFACTURER
ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO
SUPPORTING DOCUMENT

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