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

Catalog Number SCCS1002

Device Problem Computer Software Problem (1112)

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

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 sensica device was at least at one instance of time changed.And there was 2 hours time variation approximately.That happened in the middle of a patient monitoring session which resulted in incorrect timestamps data of patient urine output (uo) and core bladder temperature data.As per the communication with the customer that issue was navigated without a clinical impact.

Manufacturer Narrative

The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause could be software error.However, this cannot be confirmed.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 state the following: "the 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.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.¿ this device is not suitable for use in the presence of flammable mixtures.¿ this device is not suitable for use in oxygen rich environments.¿ 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.Warning: this product can expose you to di(2-ethylhexyl) phthalate (dehp), which is known to the state of california to cause cancer and birth defects or other reproductive harm.¿ operation warnings: ¿ federal law restricts this device to sale or use by or on the order of a licensed physician.The bd sensica¿ urine output system should only be used on the request by and under the direction of a licensed physician.¿ do not use bd sensica¿ ring (disposable) if product appears broken.¿ the ¿accuracy check¿ should be performed prior to first use, when there is a question about system accuracy, and/or after any servicing or repairs to ensure accurate measurements.Always use a new bd sensica¿ ring to complete an accuracy check.If the accuracy check fails call bd customer service at +1.844.823.5433.This self-test takes about one minute and can be accessed from the new patient and settings screen or from the administrator settings.¿ do not change time and date settings during system operation.Time and date settings should be set when system is initially installed or between monitoring sessions, if needed.¿ ensure that the urine drainage bag hanging on the bd sensica¿ ring is always below the level of the patient¿s bladder to maintain continuous, gravity flow of urine into the collection bag.¿ when connecting the single patient use bd sensica¿ ring to the system stand, use a firm, clockwise twisting motion.In order to avoid damaging components, do not apply excessive force or torque to the ring or the system¿s ring interface when connecting the device.¿ to properly stabilize the system for accurate urine output measurement, always use the bd sensica¿ tube band positioning strip provided in the bd sensica¿ ring kit to correctly position the tube band on the drainage tubing.Insert the drainage tubing in the tube holder with the tube band in the tube holder window.The band should be permanently attached to the drainage tubing using the provided peel-off adhesive backing.When removing the bag from the ring for any reason, simply pull the tubing out of the tube holder.When re-hanging the bag, reinsert the tubing into the tube holder with the tube band in the tube holder window.Do not twist or kink tubing at any time during use.The tube band positioning strip does not need to be applied when using a drainage bag that comes with pre-marked tubing.¿ during operation, keep device stand level on the floor to avoid tipping the unit over and damaging system components.Additionally, the device stand should be kept level during a monitoring session as tilting of the device may impact the accuracy of urine output measurements.¿ use the crossbar handle on the back of the device to move the bd sensica¿ urine output system.Do not pick up the device from the front of the system.Use caution not to drop the system while moving the system.¿ take care not to trip over the bd sensica¿ urine output system or the power cord to avoid user injury or accidentally pulling out the indwelling catheter.¿ do not set alarm limits to extreme values that can render the alarms useless.¿ use only the bd sensica¿ ring when using the bd sensica¿ urine output system for correct operation.¿ do not lean on, pull on, or allow anything to rest on the urine collection bag, bd sensica¿ ring or drainage tubing while the urine bag is hanging on the bd sensica¿ urine output system.This will generate a system alarm, could cause erroneous urine output readings, and may break the load cell measurement assembly.Breakage due to excessive force/weight applied to the ring or load cell assembly will constitute misuse of the system and repairs will not be covered under warranty.¿ 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.¿ the bd sensica¿ ring is a single patient use device.After ending patient monitoring, disinfect ring using facility germicide wipes.After use, the ring may be a potential biohazard.Handle and dispose in accordance with accepted medical practice, facility procedures, and applicable local, state, and federal laws and regulations.¿ do not attempt to replace the system¿s battery.Do not attempt to open control covers or repair the bd sensica¿ urine output system without proper training and approved replacement kits.To do so, may alter urine output measurements and void the warranty.Contact customer service to report system problems and arrange for product service.Note: there are no serviceable parts in the temperature monitor module.Do not attempt to open the bd sensica¿ temperature monitor module housing.¿ with the bd sensica¿ temperature monitor module, bd sensica¿ temperature sensor cable and monoplug adapter, only use a bd 400 series temperature-sensing foley catheter or equivalent.¿ do not attempt to use the bd sensica¿ urine output system with any criticore¿ disposable products.¿ after use, the bd sensica¿ urine output system, temperature monitor module, temperature sensor cable, and monoplug adapter may be a potential biohazard.Clean and disinfect the products before disposal.Handle and dispose of the products in accordance with accepted medical practice, facility procedures, and applicable local, state, and federal laws and regulations.These products contain electrical and/or electrical equipment, and the bd sensica¿ urine output system (sccs1002 and sccs1002e) contains a lithium-ion battery that must be disposed of per local laws and regulations.¿ do not simultaneously touch the patient and the visible metal contacts of the temperature monitor module or the ring interface.¿ 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 sensica device was at least at one instance of time changed.And there was 2 hours time variation approximately.That happened in the middle of a patient monitoring session which resulted in incorrect timestamps data of patient urine output (uo) and core bladder temperature data.As per the communication with the customer that issue was navigated without a clinical impact.

• Brand Name: SENSICA UO SYSTEM
• Type of Device: SENSICA URINE OUTPUT 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: 17618760
• MDR Text Key: 321950765
• Report Number: 1018233-2023-06304
• Device Sequence Number: 1
• Product Code: EXS
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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