MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO SYSTEM; SENSICA DEVICE

Model Number SCCS1002

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

It was reported that the sensica device exhibited phantom touches due to the screen being cleaned with disinfecting chemicals.The nurse also indicated that the patient had a drop in urine output from 0200 to 0400 that had otherwise been adequate (80s to single digits).The nurse released the catheter from the urometer, checked for flow multiple times, and did their best to position the catheter for optimum forward flow at least twice during this time.One issue was that the catheter tubing had to go up over the bedside rail tubing length, which they already know was an ongoing issue.The nurse again took the catheter tubing out of the urometer for a turn at 0500.It was clear there was some urine flowing into the bag while it was out of the monitor, and the nurse was hoping that the urometer would recognize this volume once reattached.The device did not detect the additional volume like they have seen happen before.Also, it was incorrectly measuring the total volume as 0 percent, even though there was clearly volume still in the bag.Then the nurse removed the tubing, emptied the bag which had about 350ml of urine and replaced it.When resumes the monitoring, it correctly showed 0 percent, but the bag started filling up with more urine while it was stabilizing and did not detect it.Once it stabilized, it still said there was no extra output.The nurse again removed the tubing and emptied the bag for an additional 250ml of urine output that it missed detecting the urine output.Once the tubing was replaced, detected, and resumed, the device started tracking urine and the volume appeared accurate.Per follow-up information received on 01mar2022, the issue sighted was managed and resolved onsite.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause is urine cannot easily flow into urine collection bag due to user hangs bag on ring without removing loops/twists in tubing.However this cannot be confirmed.Nurse checked for flow multiple times and did their best to position the catheter for optimum forward flow at least twice during this time.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.It is unknown if the device did meet specifications and whether the device was influenced by the reported failure.The device was in use on a patient.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation, no additional actions are needed.The device was not returned for evaluation.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: "to properly stabilize the system for accurate urine output measurement, always use the bd sensica¿ tube band positioning strip provided in the bd sensica¿ ring kit to correctly position the tube band on the drainage tubing.Insert the drainage tubing in the tube holder with the tube band in the tube holder window.The band should be permanently attached to the drainage tubing using the provided peel-off adhesive backing.When removing the bag from the ring for any reason, simply pull the tubing out of the tube holder.When re-hanging the bag, reinsert the tubing into the tube holder with the tube band in the tube holder window.Do not twist or kink tubing at any time during use.The tube band positioning strip does not need to be applied when using a drainage bag that comes with pre-marked tubing.During operation, keep device stand level on the floor to avoid tipping the unit over and damaging system components.Additionally, the device stand should be kept level during a monitoring session as tilting of the device may impact the accuracy of urine output measurements." h11: section 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.H3 other text : the device was not returned.

Event Description

It was reported that the sensica device exhibited phantom touches due to the screen being cleaned with disinfecting chemicals.The nurse also indicated that the patient had a drop in urine output from 0200 to 0400 that had otherwise been adequate (80s to single digits).The nurse released the catheter from the urometer, checked for flow multiple times, and did their best to position the catheter for optimum forward flow at least twice during this time.One issue was that the catheter tubing had to go up over the bedside rail tubing length, which they already know was an ongoing issue.The nurse again took the catheter tubing out of the urometer for a turn at 0500.It was clear there was some urine flowing into the bag while it was out of the monitor, and the nurse was hoping that the urometer would recognize this volume once reattached.The device did not detect the additional volume like they have seen happen before.Also, it was incorrectly measuring the total volume as 0 percent, even though there was clearly volume still in the bag.Then the nurse removed the tubing, emptied the bag which had about 350ml of urine and replaced it.When resumes the monitoring, it correctly showed 0 percent, but the bag started filling up with more urine while it was stabilizing and did not detect it.Once it stabilized, it still said there was no extra output.The nurse again removed the tubing and emptied the bag for an additional 250ml of urine output that it missed detecting the urine output.Once the tubing was replaced, detected, and resumed, the device started tracking urine and the volume appeared accurate.Per follow-up information received on 01mar2022, the issue sighted was managed and resolved onsite.

• Brand Name: SENSICA UO SYSTEM
• Type of Device: SENSICA DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13752982
• MDR Text Key: 287342430
• Report Number: 1018233-2022-01250
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: 00801741215773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/13/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other