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

Model Number SCCS1002

Device Problems Computer Software Problem (1112); Device Sensing Problem (2917); Component Misassembled (4004)

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

Event Date 01/13/2023

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 the optical sensor in sensica device was not reading actuated when a tube was present.Remained in open status when reading from utility software.Per additional information received via follow-up on (b)(6) 2023, there was no patient involvement.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause could be incorrect part geometry, however this cannot be confirmed.The device was evaluated after receipt and the unit functioned as normal.Applied foam gasket to optical sensor.The pins on the load cell were damaged.The device received updates while in for repair.The load cell was replaced and a foam gasket was applied to the optical sensor.After repair, the device passed all applicable testing.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 was reviewed and found nothing that could have caused or contributed to the reported event.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 bd 400 series temperature-sensing foley catheter or equivalent.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.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.Variations in the connection of the drainage tube to the tube holder or the bag to the ring can impact system accuracy.It is advised to not disturb the components of the bd sensica¿ urine output system while in use unless required for patient care." h11:section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the optical sensor in sensica device was not reading actuated when a tube was present.Remained in open status when reading from utility software.Per additional information received via follow-up on 26jan2023, there was no patient involvement.Per sample evaluation results received on 16feb2023, it was reported that the pins on the load cell were damaged.It was noted that the load cell was replaced, and a foam gasket was applied to the optical sensor.

Event Description

It was reported that the optical sensor in sensica device was not reading actuated when a tube was present.Remained in open status when reading from utility software.As per additional information received via follow-up on (b)(6) 2023, there was no patient involvement.As per sample evaluation results received on (b)(6) 2023, it was reported that the pins on the load cell were damaged.It was noted that the load cell was replaced, and a foam gasket was applied to the optical sensor.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is that the optical sensor is not situated correctly in the housing causing it to read incorrectly.Applied foam gasket to optical sensor.The pins on the load cell were damaged.The device received updates while in for repair.The load cell was replaced and a foam gasket was applied to the optical sensor.After repair, the device passed all applicable testing.The device did not meet specifications, and was influenced by the reported failure.The device was not in use on a patient.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 states the following: "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." 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 actual/suspected device was inspected.

• Brand Name: SENSICA UO MONITOR ICU
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16272555
• MDR Text Key: 308541844
• Report Number: 1018233-2023-00491
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 05/31/2023; 07/20/2023
• Supplement Dates FDA Received: 06/06/2023; 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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