Maquet (b)(4) requested the product in question for further investigation in the laboratory of the manufacturer on 07/17/2019, but the product is already discarded by the customer.Maquet cardiopulmonary is aware of a similar complaint #(b)(4) which was investigated with the following results: the product was investigated in the laboratory of the manufacturer.A visual inspection was performed on the returned hls module advanced 7.0.The venting membrane was contaminated and the yellow protective cap was not sent back.After the external cleaning, the protective cover of the pump was removed.The internal sensor was contaminated and corroded.The contacts and the board of the sensor are corroded.The flex conductor near solder joint has burst and torn on one side.Hls modules connected to the cardiohelp, to create a water cycle.The internal pressure sensor (delta p) is damaged that the sensor stops working.For information: after venting the oxygenator, the venting membrane was not closed again.Through the vent membrane the blood leaked, dripped onto the protective cover of the pump, ran under the cover where the internal pressure sensor is located.Thus the failure could be confirmed.The most probable root cause for the reported failure could be attributed to an user error.The venting membrane was not closed again after priming with the yellow protective cap, liquid can get into the interior and this could led to the corrosion of the sensor.What was clearly recognizable on the sensor.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.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).
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