(b)(4).The reported failure is known to mcp based on similar complaints.An internal process was started ((b)(4)) in order to investigate the root cause and implement corrective actions.Since november 2013 customers reported implausible pressure sensor readings and / or alerts displayed by the cardiohelp-i.Investigations of affected hls 7.0 oxygenators showed scaling on the solder side of the heimdall flexboard, (b)(4), at the contact pins of the venous pressure sensor.In the course of the investigation of (b)(4) it was found that the implausible pressure sensor readings and / or alerts displayed by the cardiohelp-i were caused by priming solution (saline solution) on the pins of the pressure sensor of the heimdall flexboard ((b)(4)).During priming it is unlikely but possible that priming solution (saline solution) enters the hls module and gets in contact with the contact pins of the pressure sensors of the heimdall flexboard.As the cardiohelp-i supplies electrical energy to the heimdall flexboard this can result in electrolysis at the pressure sensors.The electrolytic current then falsifies the signals of the pressure sensor.Most probable situation when saline solution can reach the heimdall flexboard is the de-airing process during the priming of the oxygenator.When the user opens the luer lock some saline can drop on the surface of the hls module 7.0 / 5.0 and from there it can flow inside to the heimdall flexboard maquet cardiopulmonary will implement a new coating of the affected piece part into serial production approx.By january 2018.
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