SENSICA UO SYSTEM

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. THE DEVICE WAS NOT RETURNED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE IS SIMULTANEOUS SOFTWARE FAILURES. HOWEVER THIS CANNOT BE CONFIRMED. IT WAS UNKNOWN IF THE DEVICE MET SPECIFICATIONS AND WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE. THE DEVICE WAS IN USE ON A PATIENT. A DHR REVIEW IS NOT REQUIRED AS THE SERIAL NUMBER IS UNKNOWN. 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." CORRECTION: 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 ON FEBRUARY 8, AN REGISTERED NURSE PROVIDED FEEDBACK TO THE SENSICA REIMPLEMENTATION SURVEY THAT ALLEGED DEFICIENCIES RELATED TO THE DEVICE PERFORMANCE AND SAFETY. THE REGISTERED NURSE RESPONDED THAT THE SENSICA URINE OUTPUT SYSTEM DID NOT MEASURE CORE BLADDER TEMPERATURE WITHIN THE SPECIFICATIONS OF THE INSTRUCTIONS FOR USE (+ OR -0.2 DEGREES C OR + OR -0.4 DEGREES F) WHEN COMPARED TO SWAN MEASUREMENTS. THE REGISTERED NURSE DOCUMENTED THAT THE SENSICA CORE BODY TEMPERATURE WAS 0.5 DEGREES F HIGHER THAN THE SWAN MEASURED TEMPERATURE.

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 ON (B)(6), A REGISTERED NURSE PROVIDED FEEDBACK TO THE SENSICA REIMPLEMENTATION SURVEY THAT ALLEGED DEFICIENCIES RELATED TO THE DEVICE PERFORMANCE AND SAFETY. THE REGISTERED NURSE RESPONDED THAT THE SENSICA URINE OUTPUT SYSTEM DID NOT MEASURE CORE BLADDER TEMPERATURE WITHIN THE SPECIFICATIONS OF THE INSTRUCTIONS FOR USE (+ OR -0.2 DEGREES C OR + OR -0.4 DEGREES F) WHEN COMPARED TO SWAN MEASUREMENTS. THE REGISTERED NURSE DOCUMENTED THAT THE SENSICA CORE BODY TEMPERATURE WAS 0.5 DEGREES F HIGHER THAN THE SWAN MEASURED TEMPERATURE.