SENSICA URINE OUTPUT SYSTEM
Received Aug 14, 2024 · Event occurred Jul 22, 2024
Report 1018233-2024-04906 · MDR key 19981405
Device
Generic name
Sensica Urine Output System
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
SCCS1002
Lot number
NA
Product problems
- Computer Operating System Problem
- Computer Operating System 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 BIOMED STATED THAT THE SENSICA URINE OUTPUT DEVICE WAS SENT DOWN TO BIOMED WITH ISSUES STARTING A SESSION. IT WAS DETERMINED THAT THE DEVICE HAD A DAMAGED LOAD CELL WITH PINS POTENTIALLY BENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS LOGGING URINE OUTPUT INCORRECTLY AND TAKING A LONG TIME TO CONNECT TO START ONCE THE URINE BAG WAS CONNECTED. THEY HAVE ASKED FOR MORE TECHNICAL CLARIFICATION REGARDING THIS INFORMATION.
Additional Manufacturer Narrative
THIS MDR IS BEING RETRACTED AS IT IS A DUPLICATE OF A RECORD ALREADY SUBMITTED 1018233-2024-04817. 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 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.
Description of Event or Problem
IT WAS REPORTED THAT THE BIOMED STATED THAT THE SENSICA URINE OUTPUT DEVICE WAS SENT DOWN TO BIOMED WITH ISSUES STARTING A SESSION. IT WAS DETERMINED THAT THE DEVICE HAD A DAMAGED LOAD CELL WITH PINS POTENTIALLY BENT. THE CUSTOMER REPORTED THAT THE DEVICE WAS LOGGING URINE OUTPUT INCORRECTLY AND TAKING A LONG TIME TO CONNECT TO START ONCE THE URINE BAG WAS CONNECTED. THEY HAVE ASKED FOR MORE TECHNICAL CLARIFICATION REGARDING THIS INFORMATION.