SENSICA UO SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS CHECKED AND THERE WAS NO PHYSICAL DAMAGE PRESENT. PER EVALUATION FINDINGS, LOAD CELL ASSEMBLY NEEDS TO BE REPLACED AND GROUND WIRE REPLACED BECAUSE THE MONITOR KEPT GIVING INCORRECT URINE OUTPUT (UO) READING.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE WAS CHECKED AND THERE WAS NO PHYSICAL DAMAGE PRESENT. PER EVALUATION FINDINGS, LOAD CELL ASSEMBLY NEEDS TO BE REPLACED AND GROUND WIRE REPLACED BECAUSE THE MONITOR KEPT GIVING INCORRECT URINE OUTPUT (UO) READING.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED. THE IDENTIFIED ROOT CAUSES IS ¿SOFTWARE ISSUES¿ AS IT WAS CONFIRMED THAT DUE TO CERTAIN SOFTWARE STEPS BEING INTERRUPTED, THAT UO WAS NOT BEING REPORTED OR CALCULATED CORRECTLY. FURTHERMORE, MULTIPLE CONTRIBUTING FACTORS WERE IDENTIFIED FOR THE UO ACCURACY ISSUE UNDER EVALUATION: ¿AMBIGUOUS IFU¿, ¿UNGRACEFUL SHUTDOWN,¿ ¿NOT FOLLOWING IFU,¿ ¿POWER ISSUES,¿ ¿SOFTWARE ANOMALY ASSESSMENT,¿ ¿PRODUCT ACQUISITION EVALUATION AND INTEGRATION," AND ¿ICU LAYOUT¿. HOWEVER, ALL THE CONTRIBUTING FACTORS ARE CORRELATED TO THE DISRUPTING SOFTWARE OPERATIONS PARTICULARLY WITH RELATION TO THE POWER SUPPLY AND UNGRACEFUL SHUTDOWNS. IT WAS A COMBINATION OF THE UNGRACEFUL SHUTDOWNS THAT FORCED THE SOFTWARE ISSUES TO BE IDENTIFIED WITH INCREASING PRECEDENCE. THESE ISSUES WERE PREVIOUSLY THOUGHT TO BE A LOWER RISK LEVEL, BUT THE CURRENT COMPLAINTS SHOW THAT THIS ASSESSMENT WAS INACCURATE. DURING EVALUATION, IT WAS CONFIRMED THAT THE DEVICE READING WAS INCORRECT. DEVICE WAS NOT PASSING LOAD CELL CALIBRATION. GROUND WIRE NEEDS TO BE REPLACED. THE GROUND WIRE WAS REPLACED. LOAD CELL ASSEMBLY NEEDS TO BE REPLACED. LOAD CELL WAS REPLACED. COMPLETED FINAL FUNCTIONAL TESTING. LOAD CELL PASSED CALIBRATION AND WAS COMPLETED AND RETURNED. THE DHR REVIEW IS NOT REQUIRED AND THE LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THIS ISSUE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.