SENSICA UO SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 DISPLAYED 4AM AS THE PREVIOUS HOUR EVEN THOUGH IT WAS NEARLY 10AM THERE ON THE CLOCK. ONLY THE TOTAL VOLUME WAS DISPLAYED AND THE OUTPUT FROM 4AM ON WAS BEING DISPLAYED UNDER CURRENT HOUR. THEY STATED THAT THE ORIGINAL NURSE THAT REPORTED THIS REMOVED THE BAG FROM THE RING FIRST TO CLEAN THE PATIENT AND AFTER RETURNING THE BAG THE PREVIOUS HOUR NEVER CHANGED TO THE NEXT HOUR AND STAYED AT 4AM. NURSE ORIGINALLY REPORTED AT 4AM. PER REVIEW OF WO NOTES ON 18AUG2025, THAT ISSUE OCCURRED DURING THE BAG REMOVAL AND RETURN PROCESS. CUSTOMER COULD NOT CONFIRM IF THE BAG WAS MOVED OR REMOVED DURING THE STABILIZATION PROCESS. NURSE WILL START A NEW SESSION AND CALL BACK IF THE ISSUE RETURNS.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. ROOT CAUSE WAS NOT ABLE TO BE ISOLATED AS UNIT WAS NOT EVALUATED. ONLY THE TOTAL VOLUME WAS DISPLAYED AND THE OUTPUT FROM 4AM ON WAS BEING DISPLAYED UNDER CURRENT HOUR. THEY STATED THAT THE ORIGINAL NURSE THAT REPORTED THIS REMOVED THE BAG FROM THE RING FIRST TO CLEAN THE PATIENT AND AFTER RETURNING THE BAG THE PREVIOUS HOUR NEVER CHANGED TO THE NEXT HOUR AND STAYED AT 4AM. NURSE ORIGINALLY REPORTED AT 4AM. PER WO REVIEW, THAT ISSUE OCCURRED DURING THE BAG REMOVAL AND RETURN PROCESS. CUSTOMER COULD NOT CONFIRM IF THE BAG WAS MOVED OR REMOVED DURING THE STABILIZATION PROCESS. NURSE WILL START A NEW SESSION AND CALL BACK IF THE ISSUE RETURNS. THE INSTRUCTIONS-FOR-USE ARE FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS CAN BE TAKEN. CORRECTION: D. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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 DISPLAYED 4AM AS THE PREVIOUS HOUR EVEN THOUGH IT WAS NEARLY 10AM THERE ON THE CLOCK. ONLY THE TOTAL VOLUME WAS DISPLAYED AND THE OUTPUT FROM 4AM ON WAS BEING DISPLAYED UNDER CURRENT HOUR. THEY STATED THAT THE ORIGINAL NURSE THAT REPORTED THIS REMOVED THE BAG FROM THE RING FIRST TO CLEAN THE PATIENT AND AFTER RETURNING THE BAG THE PREVIOUS HOUR NEVER CHANGED TO THE NEXT HOUR AND STAYED AT 4AM. NURSE ORIGINALLY REPORTED AT 4AM. PER REVIEW OF WO NOTES ON 18AUG2025, THAT ISSUE OCCURRED DURING THE BAG REMOVAL AND RETURN PROCESS. CUSTOMER COULD NOT CONFIRM IF THE BAG WAS MOVED OR REMOVED DURING THE STABILIZATION PROCESS. NURSE WILL START A NEW SESSION AND CALL BACK IF THE ISSUE RETURNS.