It involved a SingleStation Selectatec Type Backbar, a mounting unit for Sevoforane Vapourisers. It was custom built for us by a UK Company, supplied via an Irish representative company.
No vapour was being delivered to the patient while on Bypass. The Anaesthetic registrar noticed the BIS number climbing and questioned the level of anaesthesia. He reverted to IV sedation when he became suspicious. Ironically, it was team changeover time of year for anaesthtic registratrs and an inexperienced registrar was thought to be the cause. However, when reported the Hospital engineer thought there was an internal problem. The engineer rigged the gas sampling line of the Anaesthetic monitor to the Oxygenator. That normally displays the percentage of vapour that the patient is receiving from the Anaesthetic via the ventilator, and noted no vapour. Further review noted that the vaporiser valve was fitted incorrecty and worked in reverse. So, as you increased Percentage vapour, the valve closes accordingly, not opens. This was very evident with theGas sampling line.
These were 4 new Backbars ,built for us by the company outsourced the build to a UK company. Hence their email, attached to the Safety report.
The concern is that otherunits may have had these built from the same company and have not yet discovered the problem.
Reported to the Society and the Health Products Regulatory Authority (HPRA) Ireland. In accordance to the regulatory obligations under MDR (EU 2017/745) which requires medical devices distributors to conduct post market surveillance and report safety and performance issues. Oxygen care informed
Awaiting response.
Connect the gas sampling line of the Anaesthetic monitor to the gas line of the HLM beforethe patient enters the Theatre to show correct Vapour delivery. This is now part of a regular check off.