It was reported that during use with the 777f8 swan-ganz catheter, there was noted discrepancies to have caused some recent mistrust in using the product and hemosphere.During post-op day 1, the continuous cardiac output (cco) swan and hemosphere readings were: svo2 (venous oxygen saturation) 55 post calibration co 7.5 / ci 3.5, calculated fick svo2 55 co 4.3 /ci 1.9, acumen co 10.2 / ci 4.6.The acumen was not left up for long.The patient had already been treated for low index with fluid and epinephrine.Troubleshooting attempts were made by ensuring both hemospheres recalibrated with the most recent hgb and mixed venous saturation from the blood draw.They ensured accurate height and dry weight entered used in fick calculator.The swan-ganz catheter was confirmed in x-ray.The centimeter markings were confirmed with the marking in or.Adequate waveforms were on the monitor.The patient had stable core temperature and was not receiving any fluid boluses at the time.All cables were connected, secured, and not under any linens or pillows.Per the customer, this event possibly caused a delay in treating low output state.The device is not available for return.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
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