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

Model Number SCCS1002E

Device Problem Volume Accuracy Problem (1675)

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

Event Date 12/10/2021

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 demo sensica device was set up and nothing was there in the meter or bag.The device indicated a total bag volume of 2 percent.The user recalibrated the device and set up from scratch but still faced the same issues.The user also stated that they did not touch the foley meter bag.

Event Description

It was reported that the demo sensica device was set up and nothing was there in the meter or bag.The device indicated a total bag volume of 2 percent.The user recalibrated the device and set up from the scratch but still faced the same issues.The user also stated that they did not touch the foley meter bag.Per follow up information received on (b)(6) 2021 the sensica device was a demo and had never been used on a patient.The device was still having issues.The customer requested information on how to send in for repair or troubleshoot.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, g 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.

Event Description

It was reported that the demo sensica device was set up and nothing was there in the meter or bag.The device indicated a total bag volume of 2 percent.The user recalibrated the device and set up from the scratch but still faced the same issues.The user also stated that they did not touch the foley meter bag.Per follow up information received on 28dec2021 the sensica device was a demo and had never been used on a patient.The device was still having issues.The customer requested information on how to send in for repair or troubleshoot.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue is being investigated.The device did not meet specifications and the product was influenced by the reported failure.The device was not used 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." corrections: d,e,g.H11:section a through f - the information provided by bard 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 bard.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13057547
• MDR Text Key: 282706778
• Report Number: 1018233-2021-08289
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741219016
• UDI-Public: 00801741219016
• 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: 05/11/2022

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: SCCS1002E
• Device Catalogue Number: SCCS1002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 05/11/2022
• Supplement Dates FDA Received: 01/25/2022; 05/25/2022
• 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