It was reported that there the pressure readings (part, pint, pven) are incorrect.The failure occurred during training.The hls cable pins were rusty.A getinge field service technician (fst) was sent for investigation and repair.The failure could be replicated and the connection cable for disposables was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp were reviewed and no malfunction could be confirmed on the date of event.Another disposable connection cable with the same failure was investigated by getinge life cycle engineering on 2021-03-31.Deposit and oxides were found on the cable socket.By wetting the socket plane with salt-containing liquids (priming), the measurement signals were influenced by the electrical conductivity of the contamination.A service bulletin (issue 95 / 21-05-04) was published may 2021 to make the users aware that the contacts of the plug connections must not come into contact with cleaning agents, disinfectants or priming liquid.Referring to the instruction for use (ifu) of the cardiohelp, chapter 5.3 "connection the sensors", it is stated to ensure that the connected sensors are not defective and to not use, if there is a visible damage.The device was manufactured on 2019-10-10.The review of the non-conformities has been performed on 2023-12-08 for the period of 2019-10-10 to 2023-12-05.It 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.Based on the results the reported failure "pressure readings (part, pint, pven) are incorrect" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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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