As reported, during use in a cardiac arrest survivor who was unconscious, of this disposable pressure transducer (dpt), the measured blood pressure was higher than the pressure measured by the cardiologist.The cardiologist used philips hemo system with an acist cvi angio touch kit.There was no error message displayed.There was no allegation of patient injury.The product was available for evaluation.
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It was confirmed that the device was not available for evaluation as it was discarded by the facility.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.Per the ifu: 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.Abnormal pressure readings should correlate with the patients clinical manifestations.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.H3 other text : device discarded by facility.
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Additional information was received that the patient was not treated based on the erroneous values.The statement included in the initial mdr was referring to the usual protocol for treatment for low blood pressure.Furthermore, it was indicated that the measured invasive blood pressure was systolic blood pressure of 100 mmhg, the cardiologist a systolic blood pressure of 50 mmhg with the acist device.
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