One single dpt kit was received for evaluation.The reported event of inaccurate values was confirmed.Dpt sensor did not zero nor sense pressure on ev1000 monitor.Error message "selected cvp zero point out of tolerance.Check dpt" was showed on ev1000 monitor.Electrical testing showed that both input impedance and output impedance of dpt sensor were within specifications.However, zero-offset value did not meet the specification.No visible damage or defect was observed from sensor chip, solder joints, cable and cable connector.Electrical testing and visual examination suggested the out of specification condition was within the sensor chip.Poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor.Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated.A square-wave test may be performed by pulling the snap tab device and releasing quickly.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Pressure readings should correlate with the patient¿s clinical manifestations.In this event, there was no patient compromise noted.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.
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It was reported that during use in patient of this disposable pressure transducer, the central venous pressure (cvp) displayed was not correct.The expected value according to the clinical patient status was between 0-12 mmhg.However the value showed persistently without any fluctuation was 40 mmhg.Additionally, cvp waveform was not displayed.There was no error message or alarm.Replacing the dpt for another one the issue was solved.There was no allegation of patient injury.The device was available for evaluation.Patient demographics are not available.
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It was initially reported that the cvp value was incorrect without a wave form present.In the case, of physiologic parameter displaying without a waveform present, the user would be prompted to troubleshoot, as a waveform should always be present with the cvp values.This serves as a correction and the complaint no longer meets the criteria as reportable.
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