SENSICA UO SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE HAD NOT MEASURED OR ADDED 300ML AND MORE PHANTOM BOLAS OF URINE OUTPUT WHEN THE PATIENT HAD LOW URINE OUTPUT CONSISTENTLY PRIOR, AND NO ADDITIONAL URINE WAS SEEN IN THE BAG. THEY WERE ANECDOTAL AND THE PATIENT WAS ON DIALYSIS AND THE NURSE DID NOT RECALL THE DEVICE WAS IN USE.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS CONFIRMED. NO SAMPLE WAS RETURNED FOR EVALUATION. 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¿. A 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 DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE HAD NOT MEASURED OR ADDED 300ML AND MORE PHANTOM BOLAS OF URINE OUTPUT WHEN THE PATIENT HAD LOW URINE OUTPUT CONSISTENTLY PRIOR, AND NO ADDITIONAL URINE WAS SEEN IN THE BAG. THEY WERE ANECDOTAL AND THE PATIENT WAS ON DIALYSIS AND THE NURSE DID NOT RECALL THE DEVICE WAS IN USE.