It was reported that the arterial pressure (p-art) and temperature (t-art) was measured incorrectly.The hls module was investigated in the getinge laboratory on 2021-03-30.During a tightness test no leakage was noticed.The hls module was connected to a cardiohelp unit and the arterial temperature and pressure was measured over a time period of two hours.Both values were fluctuating.Upon visual inspection deposit (e.G.Due to priming fluid) at the sensors and a bent circuit board was detected.The production records of the affected hls module (dms# (b)(4)) were reviewed on 2021-04-01.According to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Based on the investigation results the reported failure "p-art and t-art reading incorrect" could be confirmed.The most probable root cause was determined as a bent circuit board leading to a damaged flexible conductor and thus a disconnecting of the arterial sensors.This was most probable caused by an assembly error in combination with external forces (e.G.Mechanical hit, humidity, fluids, temperature).The operators in the production were re trained on the bop concerning the assembling.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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