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

Model Number SCCS1002

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported that the sensica device had an unresponsive screen since the user could not interact with it due to the phantom touches.When observing the unit, the user could see an active/flashing phantom touch on the upper left side of the calculator icon.The user resolved the frozen screen by rebooting the unit a new unused unit was swapped in to continue monitoring while rebooting.No cleaning had been performed on this unit according to the nurse¿s report.The unit was sitting in a puddle of urine for some unknown amount of time.This occurred because the nurse left the twist valve opened on the meter bag.The user was told the urine never would have reached the monitor, so this is unlikely the cause.

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 confirmed.The identified root cause is the ¿identified uo inaccuracy issues were assessed by the investigation actions which served as the information used to complete the root cause evaluation using the fishbone methodology and the five why¿s.After evaluation, it was concluded that the event was caused by a single root cause with multiple contributing factors.A variety of software issues were determined to cause the various uo inaccuracies observations.The identified root causes is ¿software issues¿ as it was confirmed that due to certain software steps being interrupted, that uo was not being reported or calculated correctly.Furthermore, multiple contributing factors were identified for the uo accuracy issue under evaluation: ¿ambiguous ifu¿, ¿ungraceful shutdown,¿ ¿not following ifu,¿ ¿power issues,¿ ¿software anomaly assessment,¿ ¿product acquisition evaluation and integration," and ¿icu layout¿.However, all the contributing factors are correlated to the disrupting software operations particularly with relation to the power supply and ungraceful shutdowns.It was a combination of the ungraceful shutdowns that forced the software issues to be identified with increasing precedence.These issues were previously thought to be a lower risk level, but the current complaints show that this assessment was inaccurate.When observing the unit, the user could see an active or flashing phantom touch on the upper left side of the calculator icon.No cleaning had been performed on this unit according to the nurse¿s report.The user resolved the frozen screen by rebooting the unit.A new unused unit was swapped in to continue monitoring while rebooting.All good faith attempts have been made to obtain additional information.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.The device did not meet specifications and the product was influenced by the reported failure.The serial number was unknown; therefore, the device history record could not be reviewed.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." corrections: d,e,g 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 evaluated.

Event Description

It was reported that the sensica device had an unresponsive screen since the user could not interact with it due to the phantom touches.When observing the unit, the user could see an active/flashing phantom touch on the upper left side of the calculator icon.The user resolved the frozen screen by rebooting the unit a new unused unit was swapped in to continue monitoring while rebooting.No cleaning had been performed on this unit according to the nurse¿s report.The unit was sitting in a puddle of urine for some unknown amount of time.This occurred because the nurse left the twist valve opened on the meter bag.The user was told the urine never would have reached the monitor, so this is unlikely the cause.

• 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: 12983089
• MDR Text Key: 284816101
• Report Number: 1018233-2021-07990
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741215773
• UDI-Public: 00801741215773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SCCS1002
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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