SENSICA UO SYSTEM
Received Feb 9, 2023 · Event occurred Jan 19, 2023
Report 1018233-2023-00742 · MDR key 16334889
Device
Generic name
Sensica Device
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002ECatalog number
SCCS1002E
Lot number
NA
Product problems
- Volume Accuracy Problem
- Volume Accuracy 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 USER SET UP THE SENSICA SYSTEM, DID NOT ADD FLUID AND DID NOT DISTURB THE SYSTEM. IN THE FIRST HOUR, THE SYSTEM READ 7ML AND THE SECOND HOUR IT READ 3ML. THIS WAS OUTSIDE OF THE ACCURACY SPECIFICATION THAT MSS WOULD EXPECT WHEN THE SYSTEM WAS NOT BEING DISTURBED. AS PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 31JAN2023, THEY HAVE DECIDED TO KEEP THE SENSICA AND WOULD CONTINUE TO MONITOR THIS UNIT FOR ISSUES. IF THESE ISSUES CONTINUE, THEY WOULD SEND IT FOR EVALUATION AND REPAIR.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED. THE IDENTIFIED ROOT CAUSES IS ¿SOFTWARE ISSUES¿ AS IT WAS CONFIRMED THAT DUE TO CERTAIN SOFTWARE STEPS BEING INTERRUPTED, THAT UO WAS NOT BEING REPORTED OR CALCULATED CORRECTLY. THE DEVICE DID NOT MEET SPECIFICATIONS, AND WAS INFLUENCED BY THE REPORTED FAILURE. THE DEVICE WAS NOT IN USE ON A PATIENT. THE DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THIS ISSUE. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE USER SET UP THE SENSICA SYSTEM, DID NOT ADD FLUID AND DID NOT DISTURB THE SYSTEM. IN THE FIRST HOUR, THE SYSTEM READ 7ML AND THE SECOND HOUR IT READ 3ML. THIS WAS OUTSIDE OF THE ACCURACY SPECIFICATION THAT MSS WOULD EXPECT WHEN THE SYSTEM WAS NOT BEING DISTURBED. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6)2023, THEY HAVE DECIDED TO KEEP THE SENSICA AND WOULD CONTINUE TO MONITOR THIS UNIT FOR ISSUES. IF THESE ISSUES CONTINUE, THEY WOULD SEND IT FOR EVALUATION AND REPAIR.