SENSICA UO SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT SENSICA DEVICE WAS NOT RECOGNIZING THE TUBE IN THE TUBE HOLDER WINDOW. NURSE HAD TAKEN IT OUT AND PUT IT BACK IN SEVERAL TIMES AND ALSO TRIED CHANGING OUT THE RING WITHOUT SUCCESS. MSS ASKED ABOUT THE TUBE BAND BEING USED AND NURSE SAID THAT IT WAS IN PLACE. DUE TO THIS THEY WERE NOT ABLE TO CAPTURE AUTOMATED URINE OUTPUT (AUO) AND THIS INCREASED USE OF NURSE¿S TIME TO TROUBLESHOOT THE DEVICE INSTEAD OF COMPLETING OTHER TASKS FOR PATIENT CARE.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

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 THAT THE TUBE HOLDER UNABLE TO DETECT PRESENCE OF TUBE DUE TO PART GEOMETRY BEING TOO SMALL. HOWEVER THIS CANNOT BE CONFIRMED. IT WAS UNKNOWN IF THE DEVICE DID MEET SPECIFICATIONS AND WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE. IT WAS UNKNOWN IF THE DEVICE WAS IN USE ON A PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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. 1.3 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." THE DEVICE WAS NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT SENSICA DEVICE WAS NOT RECOGNIZING THE TUBE IN THE TUBE HOLDER WINDOW. NURSE HAD TAKEN IT OUT AND PUT IT BACK IN SEVERAL TIMES AND ALSO TRIED CHANGING OUT THE RING WITHOUT SUCCESS. MSS ASKED ABOUT THE TUBE BAND BEING USED AND NURSE SAID THAT IT WAS IN PLACE. DUE TO THIS THEY WERE NOT ABLE TO CAPTURE AUTOMATED URINE OUTPUT (AUO) AND THIS INCREASED USE OF NURSE¿S TIME TO TROUBLESHOOT THE DEVICE INSTEAD OF COMPLETING OTHER TASKS FOR PATIENT CARE.