Sensica UO System SBTS1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741215650), received between Feb 3, 2022 and Mar 8, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE SENSICA DEVICE OVERREPORTED THE URINE OUTPUT. THE DEVICE READS THE TOTAL BAG VOLUME RATHER THAN THE DIFFERENCE TO THE CURRENT HOUR. APPROXIMATELY 350 ML WERE IN THE BAG, AND THE DEVICE ADDED 349 ML TO THE FIRST 15MINUTE HOUR BLOCK. IT WAS ALSO REPORTED THAT THE TEMPERATURE WOULD RANDOMLY DROP TO 26C OR 30C AND THEN COME BACK TO THE ACTUAL TEMPERATURE OF 37.8C TO 37.9C. BIOMED DOWNLOADED THE DATA LOGS TO REVIEW, AND THE DEVICE REBOOTED AND RE-ENTERED THE PATIENT CASE. AFTER RE-ENTERING THE PATIENT CASE, THE PRIOR DATA WAS NOT DISPLAYING IN THE CURRENT HOUR OR PRIOR HOURS. THE USER NAVIGATED TO THE DATA HISTORY SCREEN AND THEN BACK TO THE MAIN MONITORING SCREEN AND ONCE BACK TO THE MAIN MONITORING SCREEN, THE DATA WAS PRESENT ON THE DEVICE. HOWEVER, IN THE PRIOR HOURS WHEN TEMPERATURE WAS NOT CONNECTED TO THE DEVICE, THE DEVICE WAS SHOWING 0.0C OR 470972. THE PATIENT CONTINUED THE MONITORING SESSION WITH NO FURTHER ISSUES. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL ON 11-FEB-2022, THE ISSUE WAS FOUND WHILE USING ON PATIENT AND THERE WAS NO IMPACT. IT WAS STATED THAT THE DEVICE INDICATES A LARGE WEIGHT WAS PLACED AROUND 319G AND MOST LIKELY A USER HIT RESUME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691357 ↗
• MalfunctionMar 8, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TUBE WAS NOT BEING DETECTED ON THE SENSICA DEVICE WHEN IT WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT THE TEMPERATURE READING WAS HIGH FOR THE PATIENT BUT WHEN REVIEWED IN PERSON THE NURSE STATED THE DEVICE WAS NOW READING NORMAL. IT WAS ALSO OBSERVED THAT THE TEMPERATURE WOULD FLUCTUATE FOR 45 SECONDS BEFORE STABILIZING WHEN THE NURSE FIRST CONNECTED THE TEMPERATURE SENSING FOLEY CATHETER TO THE DEVICE. PER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2022, THERE WAS NO IMPACT TO THE PATIENT. NURSE GOT THE TUBING DETECTED BY BEING FORCEFUL AND PUSHING THE TUBING FULLY INSIDE THE TUBE HOLDER. FURTHER TEST STILL HAD THE TUBE BEING DETECTED, SO THE DEVICE REMAINED IN USE. THE TEMPERATURE READING APPEARED NORMAL AND STABILIZED. THE PATIENT CASE WAS CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691231 ↗
• MalfunctionFeb 3, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE SENSICA DEVICE WAS READING WILDLY HIGH, AND IT HAS BEEN CONSISTENTLY DOING THIS THROUGHOUT THE PATIENT¿S HOSPITAL STAY. THE NURSE EXCHANGED THE SENSICA DEVICE FOR A NEW ONE LAST WEEK DUE TO TOUCH SCREEN PROBLEMS, BUT THAT DID NOT CHANGE HOW THE TEMPERATURE READS EITHER. MSS HAD BEEN TALKING TO CCS ABOUT IT, AND THEY DID NOT BELIEVE THE BLADDER TEMPERATURE WAS ACCURATE. BECAUSE THE ECMO CIRCUIT OR AXILLARY OR ORAL TEMPERATURES CORRELATE WITH EACH OTHER. FOR EXAMPLE, THE BLADDER TEMPERATURE WAS CURRENTLY READING 38.8, THE ORAL AND AXILLARY WERE BOTH 36.8, AND THE CIRCUIT WAS READING 36.9. THEY SHOULD BE ONE FOR THE SENSICA MONITOR WITH SERIAL NUMBER (B)(6) AND ONE FOR THE SENSICA TEMPERATURE MODULE WITH SERIAL NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447867 ↗