SENSICA UO SYSTEM
Received May 10, 2023 · Event occurred Apr 20, 2023
Report 1018233-2023-03304 · MDR key 16903772
Device
Generic name
Sensica Uo System
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 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, LOG FILES SHOW SENSICA RECORDED HOURLY UO=40ML 32% OF THE TIME, THE REPORTED EVENT IS UNCONFIRMED, THEREFORE DHR REVIEW IS NOT REQUIRED. THE LABELLING RISK REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. CORRECTIONS: D, H 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.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.