The device is expected to be returned for evaluation, but has not been received yet.Once received and the evaluation results available a supplemental report will be submitted.The device service history record review is pending.Once the results are available, a supplemental report will be submitted with the findings.
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It was reported that there was a discrepancy in svr and sv values when using the ev1000a platform system and the clearsight pump unit during patient monitoring.There was an alert message of ¿svr exceeded high limit¿ that displayed.The svr reading was close to 3000 and normal range is 800-1200.The physician was aware that the svr reading was too high for the patient¿s condition.The edwards clinical field specialist was present to assist in troubleshooting.The patient¿s blood pressure reading with the non-invasive clearsight system and the nibp cuff matched at 120¿s over 80¿s.The edwards¿s cfs noted that there was a discrepancy with the blood pressure map reading as it was over 100.The suspect clearsight pump unit was exchanged for another unit and then the parameters corrected and the blood pressure reading was appropriate.The clearsight equipment and bedside monitor were re-zeroed and they continued with the procedure with no further issues.There was no inappropriate patient treatment administered.There was no harm or injury to the patient.The edwards cfs tested the suspect pump unit and ev1000 system, without patient monitoring, 5 days later and found inaccurate readings again.Refer to 2015691-2018-04837 and 2015691-2018-04838 for the submissions for the second occurrence.
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One clearsight pump unit was received for product evaluation.The suspect pump unit was connected to a known good working clearsight system for analysis and testing.The suspect pump unit was able to zero the known working heart reference sensor (hrs) device without any issues noted.There were no error or fault messages identified.There were normal blood pressure readings and a normal waveform that were displayed.The functional test was performed and the device passed the test.There was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported event could not be confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported event; therefore, no corrective action was taken.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements.The operators manual instructs the use on these above stated factors that can lead to inaccurate values.It is unknown if user or procedural factors played a role in the stated event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.There is a second occurrence with this pump unit, refer to submission 2015691-2018-04837.Refer to submission 2015691-2018-04840 for the ev1000a platform system involved in the event.
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