SENSICA URINE OUTPUT SYSTEM
Received Jun 8, 2023 · Event occurred May 17, 2023
Report 1018233-2023-04111 · MDR key 17085937
Device
Generic name
Sensica Urine Output System
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
SCCS1002
Lot number
NA
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
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 SENSICA DEVICE REQUIRED FOAM GASKET APPLIED TO OPTICAL SENSOR AS WELL AS A FULL SYSTEM RE-IMAGE AND UPDATE TO THE LATEST SOFTWARE AND FIRMWARE VERSIONS PER LATEST FA ACTION UPDATES AS REQUESTED BY UCC. ALSO, SENSICA WAS DETECTING TUBE WHEN NO TUBE WAS PRESENT.
Additional Manufacturer Narrative
UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A DUPLICATE OF AN EVENT PREVIOUSLY REPORTED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
Description of Event or Problem
IT WAS REPORTED THAT THE SENSICA DEVICE REQUIRED FOAM GASKET APPLIED TO OPTICAL SENSOR AS WELL AS A FULL SYSTEM RE-IMAGE AND UPDATE TO THE LATEST SOFTWARE AND FIRMWARE VERSIONS PER LATEST FA ACTION UPDATES AS REQUESTED BY UCC. ALSO, SENSICA WAS DETECTING TUBE WHEN NO TUBE WAS PRESENT.