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

Catalog Number SCCS1002

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 05/04/2023

Event Type  malfunction  

Event Description

It was reported that the sensica device was monitoring on a patient and was displaying an error message 38 every 15 minutes as shown in the picture which was unacceptable to the customer.They tried rebooting the device, which did not resolve the issue.This sensica was replaced with another monitor that was not displaying the same error.After removing this sensica from the patient, they checked the electronic medical record (emr) settings.All settings matched the values in their field update guide.The team changed the electronic medical record (emr) settings to disabled and this appears to have resolved the alarming issue.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the sensica device was monitoring on a patient and was displaying an error message 38 every 15 minutes as shown in the picture which was unacceptable to the customer.They tried rebooting the device, which did not resolve the issue.This sensica was replaced with another monitor that was not displaying the same error.After removing this sensica from the patient, they checked the electronic medical record (emr) settings.All settings matched the values in their field update guide.The team changed the electronic medical record (emr) settings to disabled and this appears to have resolved the alarming issue.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause was system/firmware error causing intermittent wifi connections.However this could not be confirmed.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: "1.1 introduction this manual provides the indications, contraindications, warnings, precautions, and instructions for use with the bd sensica¿ urine output system.Carefully read this manual in its entirety before using the bd sensica¿ urine output system.Failure to follow these instructions may result in improper use of this device.Contact customer service at +1.844.823.5433 with any questions about the information contained in this manual or about the operation and safety of the bd sensica¿ urine output system.1.2 indications for use indications: the bd sensica¿ urine output system is an automated system for continuous monitoring of urine output (uo) and core bladder temperature when connected to a temperature-sensing foley catheter.Target population: the bd sensica¿ urine output system is intended for bedside monitoring of urine output for any patient with an indwelling, urological catheter, drainage tubing and collection bag, typically in critical care settings or where close monitoring of urine output is desired.The bd sensica¿ urine output system is also intended for monitoring core bladder temperature when used with the bd sensica¿ temperature monitor module and a bd 400 series temperature-sensing foley catheter or equivalent.1.3 contraindications there are no known contraindications for use with patients who have indwelling, urological catheters in place.1.Start new patient case.1.Select new patient.2.Patient id is the only required data field.3.While not required, it is also recommended to enter patient weight 2.Attach bd sensicatm ring.1.Turn the bd sensicatm ring upside down with hanger facing upward and twist in a clockwise motion to lock into place.3.Secure tube band around tubing.1.Attach positioning strip at the meter entry (for meters) or at the anti-reflux chamber (for bags).2.Use the length of the positioning strip as a guide and attach the tube band to the drainage tubing.Note: this step is not required if using a drainage bag with pre-marked tubing.4.Hang bag and insert tubing in tube holder window.1.Hang bag hook on the bd sensica¿ ring.2.Tube band should align with tube holder window.5.Attach temperature-sensing foley to bd sensica¿ temperature monitor module.1.Attach the bd sensica¿ temperature sensor cable to the temperature-sensing foley.Use a bd sensicatm monoplug adapter if needed.2.Attach the magnetic end of the sensor cable to the module.6.Complete tube compliance process.1.The compliance process takes 5 minutes.This eliminates potential artifact associated with new patient setup.2.Monitoring will begin after this process is complete.Note: skipping this process may result in a small increase in urine recorded in the first 5 minutes that is artifact.7.Patient touch screen display.8.View data.1.Accessed through data button on home screen.2.Data screens - use buttons to toggle views.3.Snapshot screen - provides past six hours of data.9.Add initial uo.1.Select the calculator icon on the home screen to manually add any urine output that is already in the bag.10.Adjust catheter use time.1.Select shutdown & actions and then edit catheter use time.2.Use the up and down arrows to adjust the catheter use time, then touch enter and save.11.Adjust patient weight.1.Select shutdown & actions and then edit patient weight.2.Use the up and down arrows to adjust the patient weight, then touch enter and save.12.Transporting a patient.1.Drain the bag prior to transport.2.Rehang the emptied bag on the ring, touch resume, and allow the system to stabilize.3.Remove the bag from the bd sensicatm urine output system for transport.4.Upon return, reattach bag and touch resume to continue monitoring.The system will automatically add any urine output to the current hour.13.Add/subtract urine output.1.Select the calculator icon on the home screen to manually adjust current hour urine output.(i.E.When taking a urine sample or irrigating the bladder)" h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the sensica device was monitoring on a patient and was displaying an error message 38 every 15 minutes as shown in the picture which was unacceptable to the customer.They tried rebooting the device, which did not resolve the issue.This sensica was replaced with another monitor that was not displaying the same error.After removing this sensica from the patient, they checked the electronic medical record (emr) settings.All settings matched the values in their field update guide.The team changed the electronic medical record (emr) settings to disabled and this appears to have resolved the alarming issue.

• Brand Name: SENSICA UO SYSTEM
• Type of Device: SENSICA UO SYSTEM
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17018874
• MDR Text Key: 316102439
• Report Number: 1018233-2023-03830
• 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,Followup
• Report Date: 10/31/2023

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 Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 09/13/2023; 10/31/2023
• Supplement Dates FDA Received: 10/06/2023; 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• 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