PERFUSION REPORTS

REPORT
139
DATE
20/5/2026
TITLE
Faulty pressure relief valve
DETAILS OF INCIDENT

During set up, the suckers on the heart lung machine were checked and double checked as per protocol, including direction and occlusion. All suckers were working as expected at this stage. Each of the suckers (blue, red, green) have a one way pressure relief valve integrated in to the sucker line. As a final check prior to use, the perfusionist and scrub nurse performed a wet sucker check to ensure the sucker is both in the correct direction and is working as expected. The scrub nurse placed the sterile end of the sucker line in to a pot of saline and the perfusionist turned the sucker on, and they both observe the sucker sucking saline back towards the heart lung machine in the correct direction, and not blowing bubbles in to the saline.

The blue sucker did not suck any saline, nor did it blow any bubbles. It just wasn't working.

DETAILS OF INJURY TO PATIENT

No harm.

TYPE OF DEVICE/MANUFACTURER

One-way valve in a LivaNova custom perfusion tubing system pack.

ACTION TAKEN

The first immediate step was to triple check the direction and  occlusion of the blue sucker, and everything was set up correctly, confirming  that there was no set up error.

 

The second step was to inform the surgeon of the issue with the blue sucker, and to use the spare green sucker instead, which was working as  expected.

 

The final step was to cut out the one way pressure relief valve in the  blue sucker to check if this was the problem (blocked or not opening  correctly). The valve was replaced by a standard 1/4 x 1/4 inch connector.  The sucker was double checked again, and a wet test performed. This time the  sucker was working as expected, suggesting that there was a problem with the valve in the blue sucker line.

RESPONSE FROM MANUFACTURER
ADDTIONAL INFORMATION

Reported to manufacturer and MHRA (Ref 2026/005/013/501/007)

SUPPORTING VISUALS/VIDEO
SUPPORTING DOCUMENT

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