MAUDE Adverse Event Report: C. R. BARD, INC. SENSICA UO SYSTEM; URINOMETER, ELECTRICAL

Model Number SCCS1002

Device Problems Break (1069); No Display/Image (1183); Failure to Transmit Record (1521); Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023); Patient Data Problem (3197)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2022

Event Type  malfunction  

Event Description

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.".

• Brand Name: SENSICA UO SYSTEM
• Type of Device: URINOMETER, ELECTRICAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 14257423
• MDR Text Key: 290453641
• Report Number: 14257423
• Device Sequence Number: 1
• Product Code: EXS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCCS1002
• Device Catalogue Number: SCCS1002
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1