PERFUSION REPORTS

REPORT
068
DATE
1/11/2020
TITLE
Venous Reservoir disposable issue
DETAILS OF INCIDENT

Whilst dismantling the bypass circuit for disposal I lifted the venous reservoir off its holder using the venous inlet connector which became detached with little force applied.

I was able to reposition the sealing washer and reattach (clip) the venous column back into the reservoir with ease but it felt just too easy to pull off and on.

(Please see picture in additional information)

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Medtronic Affinity Fusion Venous Reservoir

ACTION TAKEN

Manufacturer informed and the rest of the perfusion department informed.

Decision taken to stop using that batch until further details are received from Medtronic QA

RESPONSE FROM MANUFACTURER

Waiting on response.

ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO

Please see picture attached

SUPPORTING DOCUMENT

OTHER PERFUSION
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Detached bullet tip of sump-updated response Sep 2022
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