SENSICA URINE OUTPUT SYSTEM

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED. THE REPORTED ISSUE WAS INCONCLUSIVE. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. PER UNIT NURSE MANAGER, NO HARM OCCURRED TO PATIENT. BEDSIDE RN STOPPED THERAPY, RESTARTED DEVICE, AND RESUMED THERAPY WOULD WITHOUT ISSUE. PER ADDITIONAL INFORMATION RECEIVED, THEY WERE SURE WHICH ONE WAS DOING IT SO THEY COULD NOT SEND IT. THEY HAVE NOT EXPERIENCED THE ISSUE SINCE THEN. THE LABELING/IFU REVISION ACCOMPANYING THIS SERIAL NUMBER IS NOT RECORDED IN THE DHR. THE LATEST LABELING REVISION WAS REVIEWED FOR THIS INVESTIGATION. THE INSTRUCTIONS-FOR-USE WERE FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. A DHR REVIEW IS NOT REQUIRED AS THE SERIAL NUMBER IS UNKNOWN. CORRECTION: B UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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.

Description of Event or Problem

IT WAS REPORTED THAT THE HAVE SEEN SOME ERROR ARISE ON THE SENSICA URINE OUTPUT SYSTEM A COUPLE OF TIMES AND WAS WONDERING IF KNEW WHY OR HOW TO FIX IT. RANDOMLY DURING A SHIFT, IT WOULD STOP SHOWING THE HOURLY OUTPUTS AND COMBINE 3 OR MORE HOURS OF OUTPUT, SO THEY WOULD NOT SEE WHAT THEY PUT OUT EACH HOUR. PER UNIT NURSE MANAGER, NO HARM OCCURRED TO PATIENT. BEDSIDE RN STOPPED THERAPY, RESTARTED DEVICE, AND RESUMED THERAPY WOULD WITHOUT ISSUE. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON (B)(6) 2025, THEY WERE SURE WHICH ONE WAS DOING IT SO THEY COULD NOT SEND IT. THEY HAVE NOT EXPERIENCED THE ISSUE SINCE THEN.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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.

Description of Event or Problem

IT WAS REPORTED THAT THE HAVE SEEN SOME ERROR ARISE ON THE SENSICA URINE OUTPUT SYSTEM A COUPLE OF TIMES AND WAS WONDERING IF KNEW WHY OR HOW TO FIX IT. RANDOMLY DURING A SHIFT, IT WOULD STOP SHOWING THE HOURLY OUTPUTS AND COMBINE 3 OR MORE HOURS OF OUTPUT, SO THEY WOULD NOT SEE WHAT THEY PUT OUT EACH HOUR. PER UNIT NURSE MANAGER, NO HARM OCCURRED TO PATIENT. BEDSIDE RN STOPPED THERAPY, RESTARTED DEVICE, AND RESUMED THERAPY WOULD WITHOUT ISSUE.