PERFUSION REPORTS

REPORT

053

DATE

1/2/2020

TITLE

Arterial Line Filter Leak

DETAILS OF INCIDENT

After priming the circuit with a blood prime prior to CPB, a drip of blood was noticed on the floor. Upon closer inspection, the arterial line filter had leaked all around the seal.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Liva Nova Arterial Line Filter

Product Code: C23500

Lot/Batch: 1910240140

ACTION TAKEN

A new tubing set was opened, the filter was isolated from the circuit and removed and a new arterial line filter was inserted. The original faulty filter was drained of blood and stored according to department protocol for the manufacturer to collect. The manufacturer was contacted and an electronic incident form was completed complying with trust guidelines.

RESPONSE FROM MANUFACTURER

See Attached

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

See attached

SUPPORTING DOCUMENT

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Detached bullet tip of sump-updated response Sep 2022

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