PERFUSION REPORTS

REPORT

052

DATE

1/3/2019

TITLE

Gas Line Filter Issue

DETAILS OF INCIDENT

On-going problem with Liva Nova green gas line with filter since November 2018 (at least 10 gas lines that reported department are aware of).

Noticed pre-CPB when checking gas flow through gas line, pressure readings over 30mmHg on Maquet electronic gas blender. When gas sweep increased it alarmed at 50mmHg. When the gas line filter was disconnected the pressure returned to 0.

This has happened numerous times when using different Maquet electronic gas blenders (EGB 40). It was not noted when using Sechrist blenders as pressure readings are not available on these blenders.

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DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Liva Nova gas line

Product Code: CP8049

Ref: 08049

ACTION TAKEN

Reported to Liva Nova. 6 gas lines that were deemed faulty were collected by Liva Nova for further investigation.

Liva Nova have supplied an alternative gas line filter (Pall) in case further issues arise while using the Maquet electronic gasblender. When using the Sechrist blenders and the Liva Nova custom pack the gas line is automatically swapped for a Pall gas line.

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RESPONSE FROM MANUFACTURER

See attached below

ADDTIONAL INFORMATION

Upon reflection what do you think went well?

The issues was always identified prior to going on CPB so no patient was put at risk. Members of the perfusion team were informed quickly so all were aware and able to keep defective items. It was reported quickly to Liva Nova.

The team reflected on the use of gas blenders without the ability to notice pressure changes within the line.

New action plans/changes as a result of the event?

Liva Nova custom packs going forward will only be supplied with Pall gas line filter.

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SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

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