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

Model Number SCCS1002

Device Problem Restricted Flow rate (1248)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the sensica device was missing the urinary output measurement during an hour where the 15-minute block showed the following instead of a ml value.Per additional information received on 14-june-2022 by r and d, it was stated that the nurse found the device around the 8:00 am to 8:10 am time frame to be powered down.The device was connected to a patient.The nurse rebooted the device and restarted the patient case.The device alerted that the system was operating on battery power.Nurse reconnected the power cord connections and continued the case.Nurse then observed that the urine output for the 7am to 8am time block was reporting 0ml which was not correct.There were stars present in the 7:45am to 8:00am, 15 minute interval where the device had crashed or shut down due to low battery power.It was also found that some urine build up in the tubing right before the tube holder.The urine was still dripping into the bag and the measurement was being captured.The nurse was not concerned on the urine collecting.The tubing was coming off the bed high and had a slight lower dip in height prior to the tube holder.The urine building did not impact the nurses work.

Event Description

It was reported that the sensica device was missing the urinary output measurement during an hour where the 15-minute block showed the following instead of a ml value:.Per additional information received on (b)(6) 2022 by r and d, it was stated that the nurse found the device around the 8:00 am to 8:10 am time frame to be powered down.The device was connected to a patient.The nurse rebooted the device and restarted the patient case.The device alerted that the system was operating on battery power.Nurse reconnected the power cord connections and continued the case.Nurse then observed that the urine output for the 7am to 8am time block was reporting 0ml which was not correct.There were stars present in the 7:45am to 8:00am, 15 minute interval where the device had crashed or shut down due to low battery power.It was also found that some urine build up in the tubing right before the tube holder.The urine was still dripping into the bag and the measurement was being captured.The nurse was not concerned on the urine collecting.The tubing was coming off the bed high and had a slight lower dip in height prior to the tube holder.The urine building did not impact the nurses work.

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 of the reported issue could be due to the tube holder obstructing urine flow.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.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.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." 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.

• Brand Name: SENSICA UO SYSTEM
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14914988
• MDR Text Key: 302855167
• Report Number: 1018233-2022-05119
• 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: 10/26/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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