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U.S. Department of Health and Human Services

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

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ADAPTEC MEDICAL DEVICES LLC 3014271001 SENSICA UO MONITOR ICU; SENSICA DEVICE Back to Search Results
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.
 
Event Description
It was reported that the sensica device was not accurately measuring the urine output.
 
Manufacturer Narrative
The reported issue was inconclusive.The root cause of the reported issue could not be determined as the sample was not returned for evaluation.A potential root cause of the reported issue could be a faulty load cell.However, this cannot be confirmed.The serial number for the device associated with this particular event could not be identified by the complainant; however, the following serial numbers (b)(4), date of manufacture 09/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 08/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 09/01/218; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 09/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 08/01/2018; (b)(4), date of manufacture 09/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 08/01/2018; (b)(4), date of manufacture 09/01/2018; (b)(4), date of manufacture 09/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 08/01/2018; (b)(4), date of manufacture 10/01/2018; (b)(4), date of manufacture 09/01/2018; (b)(4), date of manufacture 04/01/2018; (b)(4), date of manufacture 03/01/2018 were in use at the time this event occurred.These serial numbers underwent a manufacturing review and the device history records found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the system software is designed to calibrate each time a new ring is attached to ensure accurate calculations of urine output volume.The sensica uo system for icu is designed to be used with any foley catheter connected to any standard urine drainage bag, with or without a urine meter.Do not use the sensica uo system with specialty disposables designed for exclusive use with other electronic urine output monitors, such as the bard criticore or protrero accuryn monitoring systems.Use of the sensica uo system with specialty disposable urine collection systems will likely yield inaccurate uo measurements." 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.H3 other text : the device was not returned.
 
Event Description
It was reported that the sensica device was not accurately measuring the urine output.
 
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Brand Name
SENSICA UO MONITOR ICU
Type of Device
SENSICA DEVICE
Manufacturer (Section D)
ADAPTEC MEDICAL DEVICES LLC 3014271001
260 james jackson avenue
cary NC 27513
MDR Report Key9362164
MDR Text Key176293068
Report Number1018233-2019-07488
Device Sequence Number1
Product Code EXS
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 02/03/2020
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 NumberSCCS1001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/01/2019
Initial Date FDA Received11/22/2019
Supplement Dates Manufacturer Received01/29/2020
Supplement Dates FDA Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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