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

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.

• 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 Key: 9362164
• MDR Text Key: 176293068
• Report Number: 1018233-2019-07488
• 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,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 Number: SCCS1001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1