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

Model Number SCCS1002

Device Problems Computer Software Problem (1112); Component Misassembled (4004)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/31/2023

Event Type  malfunction  

Event Description

It was reported that the optical sensor failed in sensica device and reading got stuck when actuated.

Manufacturer Narrative

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

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be due to part geometry.The device did not meet specifications, and was influenced by the reported failure.It was unknown if 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.The instructions for use were found adequate and states the following: "the ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.The sensica uo system for icu is designed for precise measurement using the disposable, sensica uo ring, which is part of the sensica uo patient ring kit.Each time the system is used with a new patient, a new sensica uo ring must be connected to the senica uo stand.The system software is designed to calibrate each time a new ring is attached to ensure accurate calculations of urine output volume." 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 actual/suspected device was inspected.

Event Description

It was reported that the optical sensor failed in sensica device and reading got stuck when actuated.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was that the optical sensor is not situated correctly in the housing causing it to read incorrectly.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)" 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.

Event Description

It was reported that the optical sensor failed in sensica device and reading got stuck when actuated.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16408588
• MDR Text Key: 309967680
• Report Number: 1018233-2023-01018
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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