SENSICA UO SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE HAD MEASURED OR ADDED 300 ML PLUS PHANTOM BOLAS OF URINE OUTPUT WHEN THE PATIENT HAD LOW URINE OUTPUT CONSISTENTLY PRIOR, AND NO ADDITIONAL URINE WAS SEEN IN THE BAG. THAT WAS AN ACTIVE ISSUE THAT OCCURRED ON (B)(6) 2022 AND THAT COULD BE SEEN ON THE HISTORY ON THE DEVICE. AT 9:00AM-10:00AM, THE SENSICA DEVICE ADDED 300 ML PLUS URINE OUTPUT TO THE PATIENT URINE OUTPUT COUNT. THE PATIENT WAS ON DIALYSIS AND CONSISTENTLY HAD AN OUTPUT OF 7-15ML AN HOUR BOTH PREVIOUS AND FOLLOWING 9:00-10:00AM ON (B)(6) 2022 AND OTHER THAN THIS HOUR, THE DEVICE WAS ACCURATE.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A DUPLICATE OF AN EVENT PREVIOUSLY REPORTED. 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 HAD MEASURED OR ADDED 300 ML PLUS PHANTOM BOLAS OF URINE OUTPUT WHEN THE PATIENT HAD LOW URINE OUTPUT CONSISTENTLY PRIOR, AND NO ADDITIONAL URINE WAS SEEN IN THE BAG. THAT WAS AN ACTIVE ISSUE THAT OCCURRED ON 09MAR2022 AND THAT COULD BE SEEN ON THE HISTORY ON THE DEVICE. AT 9:00AM-10:00AM, THE SENSICA DEVICE ADDED 300 ML PLUS URINE OUTPUT TO THE PATIENT URINE OUTPUT COUNT. THE PATIENT WAS ON DIALYSIS AND CONSISTENTLY HAD AN OUTPUT OF 7-15ML AN HOUR BOTH PREVIOUS AND FOLLOWING 9:00-10:00AM ON (B)(6) 2022 AND OTHER THAN THIS HOUR, THE DEVICE WAS ACCURATE.