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

Catalog Number SCCS1001

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 (b)(6) an registered nurse provided feedback to the sensica reimplementation survey that alleged deficiencies related to the device performance and safety.The registered nurse responded that the sensica urine output system did not measure urine output within the specifications of the instruction for use for two hours over the course of a 12 hour shift when compared to manual urometer measurements.Case 1 was sensica read 406ml, urometer read 335ml (22 percent above the urometer reading) case 2 was sensica read 341ml, urometer read 360ml (5.3 percent below the urometer reading).Additionally, the registered nurse noted that the sensica foley tray tubing did not drain well.

Manufacturer Narrative

The reported issue was inconclusive.The device was not returned.The root cause of the reported issue could not be determined.A potential root cause is load cell beam connection failure, underestimation of volume.However this cannot be confirmed.It was unknown if the device did meet specifications and whether the device was influenced by the reported failure.The device was in use on a patient.A dhr review is not required as the serial number is unknown.The instructions for use were found adequate and state the following: "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.Contraindications: there are no known contraindications for use with patients who have indwelling, urological catheters in place.Precautions: during system start up and in general practice, plug the bd sensica¿ urine output system into a wall power supply whenever possible.The system screen will dim when the system is unplugged to maximize battery life.After using the system on battery back-up, plug it back into the wall power supply for recharging and to avoid system shut down due to a drained battery.After removing a patient from urine output monitoring with the bd sensica¿ urine output system, shut down the system completely to avoid battery drainage while not in use.Low priority alarms may interrupt urine output monitoring and require user action to resume normal urine output monitoring functions." 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 on (b)(6), 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 urine output within the specifications of the instruction for use for two hours over the course of a 12 hour shift when compared to manual urometer measurements.Case 1 was sensica read 406ml, urometer read 335ml (22 percent above the urometer reading), case 2 was sensica read 341ml, urometer read 360ml (5.3 percent below the urometer reading) additionally, the registered nurse noted that the sensica foley tray tubing did not drain well.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause is load cell beam connection failure, underestimation of volume.However this cannot be confirmed.Case 2 was sensica read 341ml, urometer read 360ml (5.3 percent below the urometer reading).This information was received from survey.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 was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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 standard, 400 series temperature-sensing foley catheter.1.3 contraindications there are no known contraindications for use with patients who have indwelling, urological catheters in place.1.4 warnings medical electrical equipment requires special precautions regarding electromagnetic compatibility (emc) and needs to be installed and put into service according to the emc information provided in the charts at the end of these instructions for use (appendix a).Portable and mobile rf communications equipment can affect medical electrical equipment.The bd sensica¿ urine output system should not be stacked with other equipment.The bd sensica¿ urine output system has a degree of protection against electric shock of applied parts classified as type bf.This device is classified as an iec class 2 product.When using class 1 power partners peamd72-10-b2 power supply, to avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.Do not immerse or submerge the bd sensica¿ urine output stand, display monitor, ring, temperature monitor module, or temperature sensor cables in water or other liquids.Do not pour liquids over the display monitor, ring, temperature monitor or cables.If liquids accidentally spill onto device(s), wipe off liquid with soft cloth as soon as possible.See section 14 for complete care instructions.This device is not suitable for use in the presence of flammable mixtures.This device is not suitable for use in oxygen rich environments." 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 on february 8, an registered nurse provided feedback to the sensica re-implementation survey that alleges deficiencies related to the device performance and safety.The registered nurse responded that the sensica urine output system did not measure urine output within the specifications of the instruction for use for two hours over the course of a 12 hour shift when compared to manual urometer measurements.Case 1 was sensica read 406ml, urometer read 335ml (22 percent above the urometer reading), case 2 was sensica read 341ml, urometer read 360ml (5.3 percent below the urometer reading) additionally, the registered nurse noted that the sensica foley tray tubing did not drain well.

Manufacturer Narrative

The reported issue was confirmed.The registered nurse responded that the sensica urine output system did not measure urine output within the specifications of the instruction for use for two hours over the course of a 12 hour shift when compared to manual urometer measurements.Case 1 was sensica read 406ml, urometer read 335ml (22 percent above the urometer reading) case 2 was sensica read 341ml, urometer read 360ml (5.3 percent below the urometer reading).Nurse was unable to provide additional information.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 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.It is known that the device did not meet specifications and the device was influenced by the reported failure.The device was in use on a patient.The serial number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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.1.4 warnings general warnings medical electrical equipment requires special precautions regarding electromagnetic compatibility (emc) and needs to be installed and put into service according to the emc information provided in the charts at the end of these instructions for use (appendix a).Portable and mobile radiofrequency (rf) communications equipment can affect medical electrical equipment.The bd sensica¿ urine output system should not be stacked with other equipment.The bd sensica¿ urine output system has a degree of protection against electric shock of applied parts classified as type bf.This device is classified as an iec class i device.When using class 1 xp power model number: alm65us12 power supply, to avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.Do not immerse or submerge the bd sensica¿ urine output stand, display monitor, ring, temperature monitor module, temperature sensor cables, or monoplug adapter in water or other liquids.Do not pour liquids over the display monitor, ring, temperature monitor, cables or monoplug adapter.If liquids accidentally spill onto the device(s), wipe off liquid with soft cloth as soon as possible.See section 14 for complete care instructions.This device is not suitable for use in the presence of flammable mixtures.This device is not suitable for use in oxygen rich environments.Section 1: indications for use, contraindications, warnings, and cautions 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.1.4 warnings 7 the use of transducers and cables other than those specified, with the exception of transducers and cables sold as replacement parts, may result in increased emissions or decreased immunity of the bd sensica¿ urine output system.The bd sensica¿ urine output system is designed to be used with any bard¿ foley catheter and urological disposables connected to any standard urine drainage bag (2000 or 2500 ml), with or without a urine meter.If using a 400-series temperature-sensing foley catheter, see product instructions for use for mri compatibility.Refer to foley catheter instructions for use for indications and further product information.If using a 400-series temperature-sensing foley catheter, the operator is responsible for ensuring the compatibility of the temperature sensing foley catheter to the bd sensica¿ urine output system and its accessories.Incompatible components can result in degraded performance.No modification of the bd sensica¿ urine output system or any of its accessories is allowed." 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.

Event Description

It was reported that on february 8, an registered nurse provided feedback to the sensica reimplementation survey that alleged deficiencies related to the device performance and safety.The registered nurse responded that the sensica urine output system did not measure urine output within the specifications of the instruction for use for two hours over the course of a 12 hour shift when compared to manual urometer measurements.Case 1 was sensica read 406ml, urometer read 335ml (22 percent above the urometer reading) case 2 was sensica read 341ml, urometer read 360ml (5.3 percent below the urometer reading).Additionally, the registered nurse noted that the sensica foley tray tubing did not drain well.

• 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: 16467218
• MDR Text Key: 310507486
• Report Number: 1018233-2023-01393
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215612
• UDI-Public: (01)00801741215612
• 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,Followup
• Report Date: 09/28/2023

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 Catalogue Number: SCCS1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• 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