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

Model Number SCCS1002

Device Problems Device Sensing Problem (2917); Component Misassembled (4004)

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

Event Date 02/08/2023

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 misaligned, device was reading actuated when there was no tubing present.Per customer via phone on (b)(6) 2023, it was reported that the devices were not in use until the staff have been properly educated on how to use them properly.They have no idea where the complaint came from.

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.The device was evaluated upon receipt.It was found that gasket foam needs to be added to optical sensor.The manufacturing oi sccs1002x was updated as part of diet-03-6469-0004 rev 4 phase ii.Added gasket foam to optical sensor.Completed final functional testing.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: "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 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.1.5 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.If the power cord icon is displayed on the screen, the power supply is not connected.If the system is repositioned, always ensure that the power supply is fully seated on both ends.Do not disturb the system during stabilization." 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.

Event Description

It was reported that the optical sensor in sensica device was misaligned, device was reading actuated when there was no tubing present.Per customer via phone on 24feb2023, it was reported that the devices were not in use until the staff have been properly educated on how to use them properly.They have no idea where the complaint came from.

• 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: 16461512
• MDR Text Key: 310449999
• Report Number: 1018233-2023-01362
• 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
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• 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