Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The investigation showed that the problem was most likely due to a temporary fault in the pressure line.Unfortunately, this can no longer be confirmed beyond doubt, as parts were replaced on site and the error situation is no longer present.Further investigations on site are no longer possible.Regarding the pressure line and the accessory material not supplied by siemens healthineers, such as the catheter transducer system or the cannulas, new material is used for each patient.In addition, the only questionable part of our system, namely the hemo board pc1308, was replaced as a precaution.The examination by the manufacturer did not reveal any defect, which supports the above hypothesis of a temporary malfunction of the pressure line in the accessories.Nevertheless, the potentially affected parts have been exchanged by the local service organization and the error has not been reported again.The examination of the log files did not point to a product defect.The components and accessories in question were replaced and the system works as specified.A possible general error that would require corrective action of the installed base could not be determined by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.
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