MAUDE Adverse Event Report: ADAPTEC MEDICAL DEVICES LLC 3014271001 SENSICAUO RING

Catalog Number SSPK1025

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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 the device did not count urine correctly.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be part geometry - improper sizing/orientation of pcb.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: "the system software is designed to calibrate each time a new ring is attached to ensure accurate calculations of urine output volume.Any standard urine collection bag can be hung on the ring.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 up 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 device did not count urine correctly.

• Brand Name: SENSICAUO RING
• Type of Device: SENSICAUO RING
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 9511098
• MDR Text Key: 177972577
• Report Number: 1018233-2019-08174
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SSPK1025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1