MAUDE Adverse Event Report: ADAPTEC MEDICAL DEVICES LLC 3014271001 SENSICA UO MONITOR ICU

Catalog Number SCCS1001

Device Problems Incorrect Measurement (1383); Volume Accuracy Problem (1675)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 sensica device was inaccurately measuring the volume grossly for about 2 hours and the sensica unit was removed from the service.Per additional information via e-mail on 07jul2020, there was around 248ml in the bag as the patient's urine output (uo) had been 20-35ml/hr for 5 hours.Earlier, nurse had administered lasix.After doing her vitals, the bag level had significantly increased and had around 800ml in the bag.The bag was drained and urine output was measured.At the time, there was no urine entering the bag so nurse drained the bag and then clamped the foley.At the bag drain/measurement, the nurse's measurement compared to the system concluded the system was under reporting uo by several hundred ml's.The bag was again drained and the urine output was measured.The device under reported the urine output by approximately 150ml.Nurse also stated that instant update button was not active.Nurse then utilized manual methods for urine output measurements.No patient complications were noted.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue could not be determined, as the reported issue could not be reproduced.System went through initial functional test without an issue.After observing the system log file it is determined that the system went through a long period of operation without being plugged into a power source and the reported issue could be related to system having very low battery.No repairs made.Servicing of the unit was performed per test procedure.The device functioned properly and ready for use.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: "the sensica uo system for icu is designed for precise measurement using the disposable, sensica uo ring, which is part of the sensica uo patient ring kit.Each time the system is used with a new patient, a new sensica uo ring must be connected to the senica uo stand.The system software is designed to calibrate each time a new ring is attached to ensure accurate calculations of urine output volume." h11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that sensica device was inaccurately measuring the volume grossly for about 2 hours and the sensica unit was removed from the service.Per additional information via e-mail on 07jul2020, there was around 248ml in the bag as the patient's urine output (uo) had been 20-35ml/hr for 5 hours.Earlier, nurse had administered lasix.After doing her vitals, the bag level had significantly increased and had around 800ml in the bag.The bag was drained and urine output was measured.At the time, there was no urine entering the bag so she drained the bag and then clamped the foley.At the bag drain/measurement, the nurse's measurement compared to the system concluded the system was under reporting uo by several hundred ml's.The bag was again drained and the urine output was measured.The device under reported the urine output by approximately 150ml.Nurse also stated that instant update button was not active.Nurse then utilized manual methods for urine output measurements.No patient complications were noted.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA UO MONITOR ICU
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 10308253
• MDR Text Key: 200849699
• Report Number: 1018233-2020-04685
• Device Sequence Number: 1
• Product Code: EXS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCCS1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1