SENSICA UO SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE CURRENT HOUR OF URINE OUTPUT ON THE SENSICA DEVICE SHOWED 109ML OUT, BUT FRONT OF THE METER SHOWED 15ML. THIS PROMPTED THE NURSE TO LOOK AT WHEN THE BAG WAS LAST EMPTIED AND COMPARE ON WHAT THE SENSICA DEVICE SHOWED FOR TOTAL URINE OUTPUT COMPARED TO WHAT WAS PHYSICALLY IN THE BAG. SENSICA DEVICE SHOWED THAT THERE SHOULD HAVE BEEN 259ML OUT SINCE IT WAS EMPTIED, BUT WHEN NURSE EMPTIED THE BAG, IT WAS 73ML. MSS ASKED ABOUT POTENTIAL ARTIFACT AND NURSE SAID THAT THEY DID NOT THINK SO BUT DID NOTICE THAT THE LARGER DISCREPANCIES SEEMED TO BE DURING TRANSITIONAL PERIODS WHEN THE PATIENT WAS COMING ON OR OFF THE DEVICE. MSS ASKED ABOUT A NOTIFICATION AFTER IT WAS TAKEN OFF AND THEN PUT BACK ON IN LESS THAN 5 MINUTES THAT DISPLAYED AFTER STABILIZATION THAT THERE WAS AN INCREASE IN URINE THAT NURSE WANTED TO ACCEPT BUT DID NOT NOTICE THIS BUT WOULD PAY ATTENTION. MSS INFORMED THE NURSE THAT IT WOULD DISAPPEAR AFTER 30 SECONDS, ADD THE VOLUME AND IT WOULD DISAPPEAR. THE NEPHROLOGIST WAS PLEASED THAT THE URINE OUTPUT HAD INCREASED AND WAS AT A SATISFACTORY AMOUNT AND THE PATIENT DID NOT NEED HEMODIALYSIS AT THIS TIME. HOWEVER, THIS INFORMATION WAS INCORRECT. THE NURSE WAS GOING TO WATCH IT FOR A COUPLE MORE HOURS TO SEE IF THERE WERE ANY NOTIFICATIONS THAT THEY HAD MISSED BUT WAS GOING TO SWAP THE DEVICE OUT BEFORE THE END OF THEIR SHIFT. NURSE WAS GOING TO PUT A SIGN ON THE DEVICE FOR THE SENSICA TEAM TO EVALUATE THE DEVICE.

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. THIS PROMPTED THE NURSE TO LOOK AT WHEN BAG WAS LAST EMPTIED AND COMPARE WHAT SENSICA DEVICE SHOWED FOR TOTAL URINE OUTPUT COMPARED TO WHAT WAS PHYSICALLY IN THE BAG. SENSICA DEVICE SHOWED THAT THERE SHOULD HAVE BEEN 259ML OUT SINCE IT WAS EMPTIED, BUT WHEN NURSE EMPTIED THE BAG, IT WAS 73ML. MSS ASKED ABOUT POTENTIAL ARTIFACT AND NURSE SAID THAT THEY DID NOT THINK SO BUT DID NOTICE THAT THE LARGER DISCREPANCIES SEEMED TO BE DURING TRANSITIONAL PERIODS WHEN THE PATIENT WAS COMING ON OR OFF DEVICE. MSS ASKED ABOUT A NOTIFICATION AFTER IT WAS TAKEN OFF AND THEN PUT BACK ON IN LESS THAN 5 MINUTES THAT DISPLAYED AFTER STABILIZATION THAT THERE WAS IN INCREASE IN URINE THAT NURSE WANTED TO ACCEPT BUT DID NOT NOTICE THIS BUT WOULD PAY ATTENTION. MSS INFORMED THE NURSE THAT IT WOULD DISAPPEAR AFTER 30 SECONDS, ADD THE VOLUME AND IT WOULD DISAPPEAR. THIS WAS A POST-OP HEART TRANSPLANT PATIENT WITH A KNOWN ACUTE KIDNEY INJURY (AKI) AND WAS RECEIVING HEMODIALYSIS THERAPY. THE NEPHROLOGIST FOLLOWING WAS PLEASED THAT THE URINE OUTPUT HAD INCREASED AND WAS AT A SATISFACTORY AMOUNT AND DID NOT NEED HEMODIALYSIS AT THIS TIME. HOWEVER, THIS INFORMATION WAS INCORRECT. THE NURSE WAS GOING TO WATCH IT FOR A COUPLE MORE HOURS TO SEE IF THERE WERE ANY NOTIFICATIONS THAT THEY HAD MISSED BUT WAS GOING TO SWAP THE DEVICE OUT BEFORE THE END OF THEIR SHIFT. NURSE WAS GOING TO PUT A SIGN ON THE DEVICE FOR THE SENSICA TEAM TO EVALUATE THE DEVICE. ALL GOOD FAITH ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. THE OUTCOME OF THE REPAIR CANNOT BE DETERMINED AT THIS TIME. IN THE EVENT THAT INFORMATION REGARDING THE OUTCOME OF THE REPAIR AND THE STATUS OF THE DEVICE IS RECEIVED, THIS RECORD WILL BE REOPENED TO UPDATE THE INVESTIGATION. THE DEVICE DID NOT MEET SPECIFICATIONS, AND WAS INFLUENCED BY THE REPORTED FAILURE. THE DEVICE WAS IN USE ON A PATIENT. 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.

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 CURRENT HOUR OF URINE OUTPUT ON THE SENSICA DEVICE SHOWED 109ML OUT, BUT FRONT OF THE METER SHOWED 15ML. THIS PROMPTED THE NURSE TO LOOK AT WHEN THE BAG WAS LAST EMPTIED AND COMPARE ON WHAT THE SENSICA DEVICE SHOWED FOR TOTAL URINE OUTPUT COMPARED TO WHAT WAS PHYSICALLY IN THE BAG. SENSICA DEVICE SHOWED THAT THERE SHOULD HAVE BEEN 259ML OUT SINCE IT WAS EMPTIED, BUT WHEN NURSE EMPTIED THE BAG, IT WAS 73ML. MSS ASKED ABOUT POTENTIAL ARTIFACT AND NURSE SAID THAT THEY DID NOT THINK SO BUT DID NOTICE THAT THE LARGER DISCREPANCIES SEEMED TO BE DURING TRANSITIONAL PERIODS WHEN THE PATIENT WAS COMING ON OR OFF THE DEVICE. MSS ASKED ABOUT A NOTIFICATION AFTER IT WAS TAKEN OFF AND THEN PUT BACK ON IN LESS THAN 5 MINUTES THAT DISPLAYED AFTER STABILIZATION THAT THERE WAS AN INCREASE IN URINE THAT NURSE WANTED TO ACCEPT BUT DID NOT NOTICE THIS BUT WOULD PAY ATTENTION. MSS INFORMED THE NURSE THAT IT WOULD DISAPPEAR AFTER 30 SECONDS, ADD THE VOLUME AND IT WOULD DISAPPEAR. THE NEPHROLOGIST WAS PLEASED THAT THE URINE OUTPUT HAD INCREASED AND WAS AT A SATISFACTORY AMOUNT AND THE PATIENT DID NOT NEED HEMODIALYSIS AT THIS TIME. HOWEVER, THIS INFORMATION WAS INCORRECT. THE NURSE WAS GOING TO WATCH IT FOR A COUPLE MORE HOURS TO SEE IF THERE WERE ANY NOTIFICATIONS THAT THEY HAD MISSED BUT WAS GOING TO SWAP THE DEVICE OUT BEFORE THE END OF THEIR SHIFT. NURSE WAS GOING TO PUT A SIGN ON THE DEVICE FOR THE SENSICA TEAM TO EVALUATE THE DEVICE.