Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).The product was not requested to return for laboratory investigation as the failure is already known to the manufacturer and has been thoroughly investigated under a (b)(4).An investigation of oxygenators in question showed that the venous pressure sensors are probably corroded.A white crystalline substance has been found on the pins of the pressure sensor.The priming solution leads to an electrolysis when cardiohelp starts to work.The electrolysis starts instantly and causes a "short circuit" between the pins.The "short circuit" furthermore leads to implausible sensor pressure readings.It could be shown by a dried electrolyte plug that this state has obvious no impact on pressure sensor readings.It is obvious that the electrolyte (saline - priming solution) etches the pins of the plug.The most probable root cause is that varnish applied on pcb and plugs of venous pressure sensor does not resist the etching of the saline.Based on these results complaint # (b)(4) will be closed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation initiations will be completed at this time.Additional information: the product mentioned under section is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.
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