It was reported to siemens that a malfunction occurred while operating the sensis vibe hemo system.The user reported that during an interventional procedure blood pressure measurement via blood pressure cuff (nbp*) was not available.According to the cardiologists, the patient had an aortic rupture at the end of the examination.Additional information was provided that the patient passed away, however, the exact cause of death is unknown; and no relationship between the occurrence and a system malfunction was established.Siemens has requested additional information in order to conduct an investigation of the reported event.The reported event occurred in germany.
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Siemens conducted a detailed investigation of the reported event.According to the provided information, blood pressure measurement by means of a blood pressure cuff (nbp) did not work during an emergency case (patient with a heart attack).The following error message was displayed to the user: "nbp value out of range", "the nbp measurement has failed.One or more values (sys, dia, map and hf) are out of range.Please check if there is a serious problem with the patient's blood pressure".The patient had to be resuscitated at that time.After an unknown amount of time, the following message was displayed to the user: "the nbp measurement has failed.The nbp value cannot be measured due to an oscillometric signal that is too weak or not present.Check that the tubing and cuff are the correct size and fit correctly.Restart the nbp measurement" according to the physician's information, the patient died of the heart attack and an aortic rupture.From both a technical and medical perspective, the system behavior can be explained.The system reacted according to the patient's condition.In case of cardiac arrest, blood pressure cannot be measured, and the system displays above messages to the user.According to logs no failure was present at the sensis system.The system worked as specified.The sensis device did not cause nor contribute to the patient's death.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because no malfunction of the system could be detected.Internal id# (b)(4).
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