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

Catalog Number SCCS1002

Device Problem Computer Software Problem (1112)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2022

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 buttons on the display screen of sensica monitor was frozen.Per follow up information received via phone 05jan2022, initial reporter stated that the sensica device was frozen up and the nurse had to reboot the device to perform properly.Also stated that restarting the device deletes all the patient data that had been previously monitored and takes a significant amount of time for the reboot, leaving the patient without urine monitoring until reboot had finished.Per follow up information received via phone on 10jan2022, initial reporter stated that they were unsure of any impact to the patient from data being lost during reboot.Also stated that often times the nurse working with the patient would chart the data prior to restarting sensica but was unsure if the data was charted in that particular case.

Event Description

It was reported that the buttons on the display screen of sensica monitor was frozen.Per follow up information received via phone 05jan2022, initial reporter stated that the sensica device was frozen up and the nurse had to reboot the device to perform properly.Also stated that restarting the device deletes all the patient data that had been previously monitored and takes a significant amount of time for the reboot, leaving the patient without urine monitoring until reboot had finished.Per follow up information received via phone on 10jan2022, initial reporter stated that they were unsure of any impact to the patient from data being lost during reboot.Also stated that often times the nurse working with the patient would chart the data prior to restarting sensica but was unsure if the data was charted in that particular case.

Manufacturer Narrative

The reported issue was inconclusive.No sample was returned for evaluation.The root cause of the reported issue could not be determined.A potential root cause is em interference.However this cannot be confirmed.The serial number was unknown; therefore, the device history record could not be reviewed.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: 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.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.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.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.¿ the device was not returned.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA UO MONITOR
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13291425
• MDR Text Key: 286082315
• Report Number: 1018233-2022-00108
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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