SENSICA UO SYSTEM
Received May 10, 2023 · Event occurred Apr 20, 2023
Report 1018233-2023-03299 · MDR key 16902457
Device
Generic name
Sensica Uo System
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Display or Visual Feedback Problem
- Use of Device Problem
- Display or Visual Feedback Problem
- Use of Device 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 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.
Additional Manufacturer Narrative
UPON FURTHER REVIEW OF INVESTIGATION, BD HAS DETERMINED THAT THIS MDR IS NOT REPORTABLE. 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.