SENSICA UO SYSTEM

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 REGISTERED NURSE RESPONDED THAT THE SENSICA URINE OUTPUT SYSTEM DID NOT MEASURE URINE OUTPUT WITHIN THE SPECIFICATIONS OF THE INSTRUCTIONS FOR USE WHEN COMPARED TO MANUAL UROMETER MEASUREMENTS.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE IS LOAD CELL STRAIN GAUGE FAILURE. HOWEVER THIS CANNOT BE CONFIRMED. 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. 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. WARNINGS: MEDICAL ELECTRICAL EQUIPMENT REQUIRES SPECIAL PRECAUTIONS REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC) AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC INFORMATION PROVIDED IN THE CHARTS AT THE END OF THESE INSTRUCTIONS FOR USE (APPENDIX A). PORTABLE AND MOBILE RADIOFREQUENCY (RF) COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT. THE BD SENSICA¿ URINE OUTPUT SYSTEM SHOULD NOT BE STACKED WITH OTHER EQUIPMENT. THE BD SENSICA¿ URINE OUTPUT SYSTEM HAS A DEGREE OF PROTECTION AGAINST ELECTRIC SHOCK OF APPLIED PARTS CLASSIFIED AS TYPE BF. THIS DEVICE IS CLASSIFIED AS AN IEC CLASS I DEVICE. WHEN USING CLASS 1 XP POWER MODEL NUMBER: ALM65US12 POWER SUPPLY, TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH. DO NOT IMMERSE OR SUBMERGE THE BD SENSICA¿ URINE OUTPUT STAND, DISPLAY MONITOR, RING, TEMPERATURE MONITOR MODULE, TEMPERATURE SENSOR CABLES, OR MONOPLUG ADAPTER IN WATER OR OTHER LIQUIDS. DO NOT POUR LIQUIDS OVER THE DISPLAY MONITOR, RING, TEMPERATURE MONITOR, CABLES OR MONOPLUG ADAPTER. IF LIQUIDS ACCIDENTALLY SPILL ONTO THE DEVICE(S), WIPE OFF LIQUID WITH SOFT CLOTH AS SOON AS POSSIBLE. SEE SECTION 14 FOR COMPLETE CARE INSTRUCTIONS. THIS DEVICE IS NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE MIXTURES. THIS DEVICE IS NOT SUITABLE FOR USE IN OXYGEN RICH ENVIRONMENTS. 1.5 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. IF THE POWER CORD ICON IS DISPLAYED ON THE SCREEN, THE POWER SUPPLY IS NOT CONNECTED. IF THE SYSTEM IS REPOSITIONED, ALWAYS ENSURE THAT THE POWER SUPPLY IS FULLY SEATED ON BOTH ENDS. DO NOT DISTURB THE SYSTEM DURING STABILIZATION." 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.

Description of Event or Problem

IT WAS REPORTED THAT THE REGISTERED NURSE RESPONDED THAT THE SENSICA URINE OUTPUT SYSTEM DID NOT MEASURE URINE OUTPUT WITHIN THE SPECIFICATIONS OF THE INSTRUCTIONS FOR USE WHEN COMPARED TO MANUAL UROMETER MEASUREMENTS. CHARGING CABLE WAS VERY LONG, TRIPPY HAZARD BATTERY POWERED AND INACCURATE AT TIMES.