SENSICA UO SYSTEM
Received May 2, 2022 · Event occurred Mar 10, 2022
Report 14257423 · MDR key 14257423
Device
Generic name
Urinometer, Electrical
Manufacturer
C. R. Bard, Inc.Model number
SCCS1002Catalog number
SCCS1002
Product problems
- Break
- No Display/Image
- Failure to Transmit Record
- Incorrect, Inadequate or Imprecise Result or Readings
- Therapeutic or Diagnostic Output Failure
- Patient Data Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
9 INCIDENTS BETWEEN (B)(6) AND (B)(6) 2022. CATHETER SENSOR NOT WORKING, NO TEMPERATURE DISPLAYED. 1L OUT FROM FOLEY CATHETER THE PREVIOUS HOUR. THE CATHETER BAG WAS EMPTIED PRIOR TO THAT HOUR. THERE WASN'T 1L IN THE BAG, SO THE READING WAS WRONG. THE CATHETER TUBING WAS WRAPPED UP WITH THE BAG, SO THAT COULD HAVE POTENTIALLY BEEN MAKING THE DEVICE READ MORE URINE BASED ON WEIGHT. STOPPED RECORDING URINE OUTPUT, RESTARTED DEVICE MULTIPLE TIMES BUT FAILED TO COMPLETE RESTART PROCESS. NOT READING URINE OUTPUT.PATIENT WAS FOUND TO HAVE LOW URINE OUTPUT DURING THE NIGHT. SO PATIENT RECIVED 80 OF IV LASIX AND 5MG METOLAZONE. A BLADDER SCAN WAS DONE DURING THE NIGHT RESULTING IN 0. AFTER DANGLING ON THE SIDE OF THE BED THE PATIENT DROPPED 1,300ML. PATIENT STATED AFTER THAT SHE FELT LIKE SHE NEEDED TO VOID THROUGHOUT THE NIGHT. THE SENSICA ONLY READ 138ML. THE COMPUTER STATED IT HAD ANOTHER PATIENT'S INFORMATION HISTORY. THAT COMPUTER WAS DISCARDED. ANOTHER COMPUTER WAS ATTACHED AND HIS CLINIC NUMBER WAS ADDED. HOWEVER, IT STILL HAD THE OLD PATIENT'S UOP NUMBERS FROM PREVIOUS THE ADMISSION ON THE SCREEN. NURSING BEGAN CHARTING AFTER EMPTYING THE BAG UPON LANDING ON THE ICU, AND AT THE TOP OF THE HOUR, DISREGARDING OLD PATIENT'S PREVIOUS HOURS OF UOP. RING BROKEN, STILL HANGING ON SENSICA DEVICE. UNKNOWN VOLUME OF URINE NOT RECORDED RELATED TO EQUIPMENT FAILURE.DEVICE "KEEPS DYING AND SHUTTING OFF; EVEN WHEN PLUGGED IN."