SENSICA UO SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE HAD AN UNRESPONSIVE SCREEN, AND IT WAS NOT DUE TO CLEANING, BUT THE DEVICE CONTINUED TO OPERATE AND RECORD DATA. THE NURSE COULD NOT USE THE TOUCHSCREEN. THE DEVICE WAS UNRESPONSIVE DURING USE BUT CONTINUED TO RECORD AND OPERATE. THE NURSE DID NOT BELIEVE IT WAS UNRESPONSIVE DUE TO CLEANING.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE IS UNRESPONSIVE USER INTERFACE DUE TO SOFTWARE ERROR/BUGS. HOWEVER THIS CANNOT BE CONFIRMED. THE NURSE COULD NOT USE THE TOUCHSCREEN. IT WAS NOT DUE TO CLEANING, BUT THE DEVICE CONTINUED TO OPERATE AND RECORD DATA. NO FURTHER DETAILS COULD BE PROVIDED. ALL GOOD FAITH ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. THE OUTCOME OF THE REPAIR CANNOT BE DETERMINED AT THIS TIME. IN THE EVENT THAT INFORMATION REGARDING THE OUTCOME OF THE REPAIR AND THE STATUS OF THE DEVICE IS RECEIVED, THIS RECORD WILL BE REOPENED TO UPDATE THE INVESTIGATION. IT IS UNKNOWN IF THE DEVICE DID MEET SPECIFICATIONS AND WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE. IT IS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: INDICATIONS FOR USE: INDICATIONS: THE BD SENSICA¿ URINE OUTPUT SYSTEM IS AN AUTOMATED SYSTEM FOR CONTINUOUS MONITORING OF URINE OUTPUT (UO) AND CORE BLADDER TEMPERATURE WHEN CONNECTED TO A TEMPERATURE-SENSING FOLEY CATHETER. TARGET POPULATION: THE BD SENSICA¿ URINE OUTPUT SYSTEM IS INTENDED FOR BEDSIDE MONITORING OF URINE OUTPUT FOR ANY PATIENT WITH AN INDWELLING, UROLOGICAL CATHETER, DRAINAGE TUBING AND COLLECTION BAG, TYPICALLY IN CRITICAL CARE SETTINGS OR WHERE CLOSE MONITORING OF URINE OUTPUT IS DESIRED. THE BD SENSICA¿ URINE OUTPUT SYSTEM IS ALSO INTENDED FOR MONITORING CORE BLADDER TEMPERATURE WHEN USED WITH THE BD SENSICA¿ TEMPERATURE MONITOR MODULE AND A BD 400 SERIES TEMPERATURE-SENSING FOLEY CATHETER OR EQUIVALENT. CONTRAINDICATIONS: THERE ARE NO KNOWN CONTRAINDICATIONS FOR USE WITH PATIENTS WHO HAVE INDWELLING, UROLOGICAL CATHETERS IN PLACE. PRECAUTIONS: DURING SYSTEM START UP AND IN GENERAL PRACTICE, PLUG THE BD SENSICA¿ URINE OUTPUT SYSTEM INTO A WALL POWER SUPPLY WHENEVER POSSIBLE. THE SYSTEM SCREEN WILL DIM WHEN THE SYSTEM IS UNPLUGGED TO MAXIMIZE BATTERY LIFE. AFTER USING THE SYSTEM ON BATTERY BACK-UP, PLUG IT BACK INTO THE WALL POWER SUPPLY FOR RECHARGING AND TO AVOID SYSTEM SHUT DOWN DUE TO A DRAINED BATTERY. AFTER REMOVING A PATIENT FROM URINE OUTPUT MONITORING WITH THE BD SENSICA¿ URINE OUTPUT SYSTEM, SHUT DOWN THE SYSTEM COMPLETELY TO AVOID BATTERY DRAINAGE WHILE NOT IN USE. LOW PRIORITY ALARMS MAY INTERRUPT URINE OUTPUT MONITORING AND REQUIRE USER ACTION TO RESUME NORMAL URINE OUTPUT MONITORING FUNCTIONS. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE SENSICA DEVICE HAD AN UNRESPONSIVE SCREEN, AND IT WAS NOT DUE TO CLEANING, BUT THE DEVICE CONTINUED TO OPERATE AND RECORD DATA. THE NURSE COULD NOT USE THE TOUCHSCREEN. THE DEVICE WAS UNRESPONSIVE DURING USE BUT CONTINUED TO RECORD AND OPERATE. THE NURSE DID NOT BELIEVE IT WAS UNRESPONSIVE DUE TO CLEANING.