REPORT
042
DATE
Apr 2020
TITLE
Leaking ALF
DETAILS OF INCIDENT

Liva Nova D130 Dideco Kids Arterial Line Filter leaking during priming.

The leak seemed to be coming from the join between the two faces of the filter. This was found on two separate occasions and changed out both times prior to going on bypass. In both instances the leak was noticed when blood priming the circuit.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Liva Nova D130 Paediatric ALF

Product Code: C23500

Lot/Batch: 1910240140

ACTION TAKEN

Liva Nova were contacted after each event and each faulty ALF was sent back for testing.

RESPONSE FROM MANUFACTURER

See attached

ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO

See attached

SUPPORTING DOCUMENT

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