MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICAUO RING

Model Number SCCS1002

Device Problems Defective Component (2292); Operating System Becomes Nonfunctional (2996)

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

Event Date 12/17/2021

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 sometimes, the ring (sspk1025) was not being recognized by sensica device (sccs1002).This happened a lot when the screen was frozen, and the system was restarted.This also happened when patients were transported to a new unit with a new sensica.This also happened when the patient traveled for imaging and came back to the room later.When the patient returned and the ring was placed on the device, the patient id was not recognized.The patient mrn was being used.The mrn was consistent in all cases.Case sensitivity was being taken into consideration as well.No noticeable load cell was damaged and using a new ring resolved the issue.

Event Description

It was reported that sometimes, the ring (sspk1025) was not being recognized by sensica device (sccs1002).This happened a lot when the screen was frozen, and the system was restarted.This also happened when patients were transported to a new unit with a new sensica.This also happened when the patient traveled for imaging and came back to the room later.When the patient returned and the ring was placed on the device, the patient id was not recognized.The patient mrn was being used.The mrn was consistent in all cases.Case sensitivity was being taken into consideration as well.No noticeable load cell was damaged and using a new ring resolved the issue.Per email response received on (b)(6) 2021, it was stated that the device number was still unknown, and a patient was involved but unaffected by the issue.The sensica device was repaired on site.The issue was resolved by using a new unused ring.

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 sometimes, the ring (sspk1025) was not being recognized by sensica device (sccs1002).This happened a lot when the screen was frozen, and the system was restarted.This also happened when patients were transported to a new unit with a new sensica.This also happened when the patient traveled for imaging and came back to the room later.When the patient returned and the ring was placed on the device, the patient id was not recognized.The patient mrn was being used.The mrn was consistent in all cases.Case sensitivity was being taken into consideration as well.No noticeable load cell was damaged and using a new ring resolved the issue.Per email response received on 28dec2021, it was stated that the device number was still unknown, and a patient was involved but unaffected by the issue.The sensica device was repaired onsite.The issue was resolved by using a new unused ring.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was confirmed to be a detective disposable patient ring.This happened a lot when the screen was frozen, and the system was restarted.This also happened when patients were transported to a new unit with a new sensica.This also happened when the patient traveled for imaging and came back to the room later on sensica.When the patient returned and the ring was placed on the device, the patient id was not recognized.The patient mrn was being used.The mrn was consistent in all cases.Case sensitivity was being taken into consideration as well.No noticeable load cell was damaged and using a new ring resolved the issue.Per email response received on 28dec2021, it was stated that the device number was still unknown, and a patient was involved but unaffected by the issue.The sensica device was repaired onsite.The issue was resolved by using a new unused ring.The device did not meet specifications, and was influenced by the reported failure.The device was in use by a patient.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: :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." correction: f,g,h 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: SENSICAUO RING
• Type of Device: SENSICAUO RING
• 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: 13126141
• MDR Text Key: 285045044
• Report Number: 1018233-2021-08634
• 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,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• 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: SSPK1025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• 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