It was reported that the hl20 pump displayed the error message: "head error" during routine check.No harm to any person has been reported.A getinge field service technician (fst) was onsite for an investigation.The fst recalibrated the optical tacho board and cleaned the tacho strobe foil.After that the error message: "head error" was not present anymore.Full functional check has been performed.The device is back in clinical use.Thus the reported failure could be confirmed.The most probable root cause could be determined as a dirty tacho strobe foil.Because the sensor no longer detects one or more marks on the tacho strobe foil, it measures an apparently low speed at the pump head.Furthermore the failure mode "head error" can be linked to the following most possible root causes according to the hl 20 risk management file: failure of pump control board.Defective/ dirty tacho, relay or pump belt.The device in question was manufactured on 2016-10-27.The review of the non-conformities during the period of 2016-10-27 to 2023-05-24 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device caused the complaint and was not able to work as per factory¿s specifications.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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