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

Catalog Number SCCS1002E

Device Problem Component Misassembled (4004)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is the optical sensor is not situated correctly in the housing causing it to read incorrectly.A dhr is not required as this is event not an out-of-box failure and therefore is not manufacturing related.The instructions for use were found adequate and state the following: "the ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.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.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.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.Do not immerse or submerge the bd sensica¿ urine output stand, display monitor, ring, temperature monitor module, temperature sensor cables, or mono plug adapter in water or other liquids.Do not pour liquids over the display monitor, ring, temperature monitor, cables or mono plug 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.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.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.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 actual/suspected device was inspected.

Event Description

It was reported there was a defect inside front interface housing on the sensica device.Per sample evaluation results received on (b)(6) 2023, it was reported that the gasket foam needed to be applied to optical sensor.

• 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: 17772996
• MDR Text Key: 323717988
• Report Number: 1018233-2023-06883
• 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
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCCS1002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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