It was reported that the temperature of the main side circuit of the hcu30 stopped rising.A getinge field service technician (fst) was on site and investigated the hcu30 in question.The fst confirmed the reported failure that the temperature stopped rising, due to a defective hcu 30 three way valve main (material#701020562) and the actuator 24v ac/dc (material#701034052).After the replacement the device is working as intended.A defective ¿3way valve¿ was investigated in the life cycle engineering (lce).The valve can be blocked by particles/deposits, which cause a permanent leakage to the tank.The most probable root cause could be determined by the deposits inside the valve.If the hcu30 was switched off while the 3-way-valve was in open position, it is possible that the "deposits" stuck the valve in this position and the spring of the actuator has not enough power to close the valve when the device is put in operation again.The review of the non-conformities has been performed on 2021-10-04 for the period of 2017-09-16 to 2021-06-07.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.Therefore, the most probable root cause for the failure temperature no stopped rising, is a defective 3-way valve and a defective actuator.Based on these investigation results the reported failure could be confirmed.The occurrence rate was calculated for the reported issue 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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