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 AFTER THE PATIENT WAS PLACED ON LASIX, TWO-HOUR BLOCKS WERE LOST BETWEEN 11:00 AM TO 1:00 PM IN THE SENSICA DEVICE. HOWEVER, THE HOUR BLOCKS AND MEASUREMENTS RETURNED AFTER THE 1:00 PM TO 2:00 PM HOUR BLOCK. NURSE PROVIDED A PHOTO OF THE MISSING 11:00AM TO 12:00PM HOUR BLOCK, BUT THE PHOTO WAS TAKEN BEFORE THE 12:00 TO1:00 PM HOUR FINISHED, SO ONLY ONE HOUR BLOCK WAS MISSING. SENSICA DEVICE WAS WORKING ACCURATELY UP TO 11:00 AM BUT STOPPED PRIOR TO 11:00 AM WHEN THE PATIENT WAS PLACED ON LASIX. NURSE DID NOT KNOW WHAT TIME THE PATIENT WAS PLACED ON LASIX, BUT NURSE DOUBT IT WAS ON THE TOP OF THE HOUR. IF NEEDED, BIOMED COULD ASK FOR THIS TO BE CONFIRMED. AFTER A HIGH URINE OUTPUT, THE TIME BLOCKS FOR BOTH 11:00 AM TO 12:00 PM AND 12:00 PM TO 1:00 PM WERE DISAPPEARED COMPLETELY. ACCORDING TO NURSE, AN ERROR MESSAGE HAD APPEARED, AND THE NURSE REPORTED NO OTHER MESSAGES APPEARING. AT 2:00PM, THE PREVIOUS TWO MISSING TIME BLOCKS WERE RETURNED WITH THE MEASUREMENTS. SENSICA WORKED CORRECTLY FROM THEN ON AT LEAST UNTIL THE VISIT AT METHODIST. PER INFORMATION RECEIVED ON 09MAR2022, THE DEVICE WAS STILL WORKING PROPERLY EVEN WITH HIGH URINE OUTPUT FROM THE SAME PATIENT.

Additional Manufacturer Narrative

THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POTENTIAL ROOT CAUSE IS IS SOFTWARE ISSUES. IT IS UNKNOWN IF THE DEVICE MET SPECIFICATIONS AND WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE.  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. CORRECTION: G 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 AFTER THE PATIENT WAS PLACED ON LASIX, TWO-HOUR BLOCKS WERE LOST BETWEEN 11:00 AM TO 1:00 PM IN THE SENSICA DEVICE. HOWEVER, THE HOUR BLOCKS AND MEASUREMENTS RETURNED AFTER THE 1:00 PM TO 2:00 PM HOUR BLOCK. NURSE PROVIDED A PHOTO OF THE MISSING 11:00AM TO 12:00PM HOUR BLOCK, BUT THE PHOTO WAS TAKEN BEFORE THE 12:00 TO1:00 PM HOUR FINISHED, SO ONLY ONE HOUR BLOCK WAS MISSING. SENSICA DEVICE WAS WORKING ACCURATELY UP TO 11:00 AM BUT STOPPED PRIOR TO 11:00 AM WHEN THE PATIENT WAS PLACED ON LASIX. NURSE DID NOT KNOW WHAT TIME THE PATIENT WAS PLACED ON LASIX, BUT NURSE DOUBT IT WAS ON THE TOP OF THE HOUR. IF NEEDED, BIOMED COULD ASK FOR THIS TO BE CONFIRMED. AFTER A HIGH URINE OUTPUT, THE TIME BLOCKS FOR BOTH 11:00 AM TO 12:00 PM AND 12:00 PM TO 1:00 PM WERE DISAPPEARED COMPLETELY. ACCORDING TO NURSE, AN ERROR MESSAGE HAD APPEARED, AND THE NURSE REPORTED NO OTHER MESSAGES APPEARING. AT 2:00PM, THE PREVIOUS TWO MISSING TIME BLOCKS WERE RETURNED WITH THE MEASUREMENTS. SENSICA WORKED CORRECTLY FROM THEN ON AT LEAST UNTIL THE VISIT AT METHODIST. PER INFORMATION RECEIVED ON 09MAR2022, THE DEVICE WAS STILL WORKING PROPERLY EVEN WITH HIGH URINE OUTPUT FROM THE SAME PATIENT.