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

Catalog Number SCCS1002

Device Problem Volume Accuracy Problem (1675)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported that the urimeter stopped working again the previous night.Nurse stated that this time it was spontaneous, not related to foley change out or anything like that.They had to power the device off and restart it again, and to add a new ring.The nurse who troubleshooted the previous night said changing out the ring was the only way they could get it to work.This was at least their third ring.Per additional information received on 09dec2021, nurse stated that the device stopped measuring urine output.Also stated that the screen was working, and they had given a big dose of lasik's to the patient, but it did not measure any of the nearly 500 cc output that hour.There was no turn involved, nor catheter flushing, nor catheter exchange.They turned it off and on again, still it did not work.They tried a new ring and it started to work.Nurse said that something was wrong with where the ring connected, but they were not sure.

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 urimeter stopped working again the previous night.Nurse stated that this time it was spontaneous, not related to foley change out or anything like that.They had to power the device off and restart it again, and to add a new ring.The nurse who troubleshooted the previous night said changing out the ring was the only way they could get it to work.This was at least their third ring.Per additional information received on (b)(6)2021, nurse stated that the device stopped measuring urine output.Also stated that the screen was working, and they had given a big dose of lasik's to the patient, but it did not measure any of the nearly 500 cc output that hour.There was no turn involved, nor catheter flushing, nor catheter exchange.They turned it off and on again, still it did not work.They tried a new ring and it started to work.Nurse said that something was wrong with where the ring connected, but they were not sure.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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 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: 13060609
• MDR Text Key: 282979093
• Report Number: 1018233-2021-08335
• 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: 04/01/2022

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 Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 04/01/2022
• 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