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

Model Number SCCS1002

Device Problem Volume Accuracy Problem (1675)

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

Event Date 02/10/2023

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 on february 8, a registered nurse provided feedback to the sensica reimplementation survey that alleges deficiencies related to the device performance and safety.The registered nurse responded that the sensica urine output system did not measure core bladder temperature within the specifications of the instruction for use (+/-0.2 degrees c or +/-0.4 degrees f) when compared to swan measurements.The registered nurse documented that the sensica core body temperature was 0.5 degrees f higher than the swan measured temperature.Note, the form documents â¿¿+0.5c all shiftâ¿쳌, but it was confirmed that the cox cvicu unit used fahrenheit measurements as opposed to celsius.Additionally, the registered nurse responded that the sensica urine output system did not measure urine output within the specifications of the instruction for use when compared to manual urometer measurements.

Event Description

It was reported that on february 8, an registered nurse provided feedback to the sensica reimplementation survey that alleges deficiencies related to the device performance and safety.The registered nurse responded that the sensica urine output system did not measure core bladder temperature within the specifications of the instruction for use (+/-0.2 degrees c or +/-0.4 degrees f) when compared to swan measurements.The registered nurse documented that the sensica core body temperature was 0.5 degrees f higher than the swan measured temperature.Note, the attached form documents â¿¿+0.5c all shiftâ¿쳌 but it was confirmed that the cox cvicu unit used fahrenheit measurements as opposed to celsius.Additionally, the registered nurse responded that the sensica urine output system did not measure urine output within the specifications of the instruction for use when compared to manual urometer measurements.

Manufacturer Narrative

The reported issue was confirmed design related.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.Registered nurse responded that the sensica urine output system did not measure urine output within the specifications of the instruction for use when compared to manual urometer measurements.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 dhr review is not required.A labeling review is not required because labeling could not have prevented this issue 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.

• 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: 16466962
• MDR Text Key: 310504153
• Report Number: 1018233-2023-01377
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: (01)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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2023
• 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