SENSICA URINE OUTPUT SYSTEM
Received Apr 23, 2025 · Event occurred Apr 18, 2025
Report 1018233-2025-02957 · MDR key 21893137
Device
Generic name
Sensica
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PROBLEM STATED BY THE RN STAFF WAS THAT THE SENSICA URINE OUTPUT DEVICE WAS NOT STABILIZED TO READ THE URINE OUTPUT. THEY CHECKED FOR ANY DAMAGE ON THE THREE PRONG CONNECTORS WHERE THE O RING CONNECTS TO AND THEY DID NOT LOOK DAMAGED.
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.
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE SENSICA URINE OUTPUT SYSTEM WAS EVALUATED UPON RECEIPT. DURING THE EVALUATION IT WAS FOUND THAT THERE COULD BE A POTENTIAL CALIBRATION ISSUE WITH LOAD CELL. NO ERROR CODE OBSERVED. RECALIBRATED DEVICES LOAD CELL. DEVICE DID NOT EXHIBIT ANY STABILIZATION ISSUES AFTER LOAD CELL CALIBRATION. TESTING WAS PERFORMED IN ACCORDANCE WITH SR-03-6469-0002. 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 DHR IS NOT REQUIRED AS THE DEVICE HAS UNDERGONE PREVIOUS SERVICING AND THEREFORE THE REPORTED ISSUE IS NOT MANUFACTURING RELATED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTIONS: D, H. 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 PROBLEM STATED BY THE RN STAFF WAS THAT THE SENSICA URINE OUTPUT DEVICE WAS NOT STABILIZED TO READ THE URINE OUTPUT. THEY CHECKED FOR ANY DAMAGE ON THE THREE PRONG CONNECTORS WHERE THE O RING CONNECTS TO AND THEY DID NOT LOOK DAMAGED.