SENSICA UO SYSTEM

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE REPORTED ISSUE COULD NOT BE REPRODUCED. PER INVESTIGATION PRESENTATION, THE DEVICE LOGS DO NOT SHOW CONSECUTIVE HOURS OF NO UO WHILE ACTIVELY MONITORING. THE ONLY INSTANCE OF NO UO FOR CONSECUTIVE HOURS WAS WHEN THE DEVICE SHUTDOWN. THE REPORTED EVENT IS UNCONFIRMED, DHR REVIEW IS NOT REQUIRED. THE LABELLING RISK REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. 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 MONITOR FREEZES AND POWERS DOWN, WHICH LOSES ALL DATA ON THE SENSICA URINE OUTPUT SYSTEM. OCCURS EVEN WHEN PLUGGED. IF DATA WAS PRESENT, IT WAS ERASED. THE DEVICE WAS PLUGGED IN. USERS EXPRESS INACCURATE HOURLY URINE OUTPUT . NURSE CONFIRMED THE BAG HAD LESS THAN 40CC AND THE DEVICE DID NOT CAPTURE. NO DEPENDENT LOOPS WERE OBSERVED. USERS REPORT NO URINE OUTPUT FOR UP TO 6 HOURS WHILE MONITORING ACTIVELY IN PROGRESS. BAG WAS EMPTIED WITHOUT MONITORING.

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 MONITOR FREEZES AND POWERS DOWN, WHICH LOSES ALL DATA ON THE SENSICA URINE OUTPUT SYSTEM. OCCURS EVEN WHEN PLUGGED. IF DATA WAS PRESENT, IT WAS ERASED. THE DEVICE WAS PLUGGED IN. USERS EXPRESS INACCURATE HOURLY URINE OUTPUT. NURSE CONFIRMED THE BAG HAD LESS THAN 40CC AND THE DEVICE DID NOT CAPTURE. NO DEPENDENT LOOPS WERE OBSERVED. USERS REPORT NO URINE OUTPUT FOR UP TO 6 HOURS WHILE MONITORING ACTIVELY IN PROGRESS. BAG WAS EMPTIED WITHOUT MONITORING.