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

Model Number SCCS1002

Device Problems Display or Visual Feedback Problem (1184); Operating System Becomes Nonfunctional (2996)

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

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the touchscreen in sensica device was consistently registering touches in places other where the user was touching the device while attempting to.The user cleaned the screen with pdi easy screen wipes and noticed the phantom touches continued.Then shut down the device and rebooted.The phantom touches persisted upon reboot.The user removed the device from service.

Manufacturer Narrative

The device was not returned.The reported issue was confirmed design related the root cause of the reported issue is being investigated.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.The device history record review was not required as the complaint was addressed by existing capa.Labeling review was not required as the complaint was addressed by existing capa.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 device was not returned.

Event Description

It was reported that the touchscreen in sensica device was consistently registering touches in places other where the user was touching the device while attempting to.The user cleaned the screen with pdi easy screen wipes and noticed the phantom touches continued.Then shut down the device and rebooted.The phantom touches persisted upon reboot.The user removed the device from service.

Manufacturer Narrative

The reported issue was confirmed design related.The user cleaned the screen with pdi easy screen wipes and noticed the phantom touches continued.Then shut down the device and rebooted.The phantom touches persisted upon reboot.The user removed the device from service.Per additional information received on 14june2022 by r and d, it was stated that the device was later found to be in working condition by the user.No details were available regarding the events to bring the device back to service.Further background on the issue directly from the nurse included that they attempted to use the calculator by pressing 5, but could not due to a phantom touch in the center of the screen during the patient monitoring session.Nurse cleaned the screen with pdi easy screen wipes (gray cap bottles) and then rebooted the system by pressing the power button.After the system rebooted and returned to the active patient session, nurse attempted to press "5" again on the calculator.However, the phantom touch was still present and prevented them from doing so.It was unlikely but possible through effort and luck that one can still hit or open something on the screen despite the phantom touch (such as opening the calculator).Nurse could not find out what originally caused the phantom touch or exact location, but they managed to at least initially open the calculator with a phantom touch possibly present.Nurse did not notice it until attempting to use the calculator.As for the problem persisting after cleaning the screen and reboot, they believed the original cause (or maybe a new one) of the phantom touch was still present or would later cause a phantom touch in the same location.The nurse did not notice the phantom touch again until they attempted the calculator again.If the phantom touch was already present, nurse somehow managed to open the calculator a second time.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.The identified root cause is the ¿firmware¿ of the sensica.Sensica firmware is not able to distinguish between human touch, cleaning liquid, and salt residue.In addition, with cleaning practices that increased more build up in salt residue and cleaning liquid it would cause phantom touches and screen responsivity to occur.This situation is then amplified with contributing factors such as ¿cleaning agents¿, ¿customers ifu oversights¿, ¿covid era¿ and ¿ifu not in alignment with cleaning validation¿.During the covid era period (early 2020- 2022) the frequency of cleaning was heavily increased.Healthcare professionals would clean the device each time they would enter the room according to their protocols.This increased frequency of cleaning and contributed to more residues build up which led to screen unresponsiveness.Additionally, the use of bleach based ¿cleaning agents¿ used by healthcare professionals contributed to more residues build up, because the use of bleach agents left larger amounts of residual salts after cleaning.Furthermore, ¿customers ifu oversights¿, in ifu (section 14, table 9), directed to wipe the screen and remove built up residue with a secondary clothe.This led to increased amount of salt residue because of the bleach agents and frequent cleaning practices.However, all the contributing factors stem from the firmware¿s recognition of sensitivity to capture accurate touch responses and prevent screen unresponsiveness.The following root causes/contributing factors were identified: 1.Firmware ¿ root cause.2.Cleaning agents ¿ contributing factor.3.Customer ifu oversights ¿ contributing factor.4.Covid era ¿ contributing factor.5.Ifu not in alignment with cleaning validation ¿ contributing factor.The instructions for use were found adequate and state the following: "do not sterilize any component of the bd sensica¿ urine output system.To clean the display touch screen, wipe with a soft cloth or use a germicide wipe such as super sani-cloth®.Do not spray harsh cleaners directly on the display touch screen.See section 14 for complete care and maintenance of the bd sensica¿ urine output system." correction: g.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 touchscreen in sensica device was consistently registering touches in places other where the user was touching the device while attempting to.The user cleaned the screen with pdi easy screen wipes and noticed the phantom touches continued.Then shut down the device and rebooted.The phantom touches persisted upon reboot.The user removed the device from service.Per additional information received on 14june2022 by r and d, it was stated that the device was later found to be in working condition by the user.No details were available regarding the events to bring the device back to service.Further background on the issue directly from the nurse included that they attempted to use the calculator by pressing 5, but could not due to a phantom touch in the center of the screen during the patient monitoring session.Nurse cleaned the screen with pdi easy screen wipes (gray cap bottles) and then rebooted the system by pressing the power button.After the system rebooted and returned to the active patient session, nurse attempted to press "5" again on the calculator.However, the phantom touch was still present and prevented them from doing so.It was unlikely but possible through effort and luck that one can still hit or open something on the screen despite the phantom touch (such as opening the calculator).Nurse could not find out what originally caused the phantom touch or exact location, but they managed to at least initially open the calculator with a phantom touch possibly present.Nurse did not notice it until attempting to use the calculator.As for the problem persisting after cleaning the screen and reboot, they believed the original cause (or maybe a new one) of the phantom touch was still present or would later cause a phantom touch in the same location.The nurse did not notice the phantom touch again until they attempted the calculator again.If the phantom touch was already present, nurse somehow managed to open the calculator a second time.

• 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: 13417452
• MDR Text Key: 284829893
• Report Number: 1018233-2022-00297
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• 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
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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