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

Catalog Number SCCS1001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); 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 monitor stated there was only 20 mls of urine in the bag when there was actually 300 mls.

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 wire assembly.However, this cannot be confirmed.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: "with standard bag, start measurement where tubing enters bag at anti-reflux chamber.With urine meter bag, start measurement where tubing enters plastic urine meter.Remove backing from strip to expose a light glue for attaching strip to tubing as an aid in measuring the tubing length.The urine is measured once it enters the bag.The measurement is recorded after the urine bolus settles for a few seconds.This delay helps ensure that the measurement is accurate, and doe snot reflect artifact." corrections: concomitant medical products, labeled for single use.

Event Description

It was reported that the monitor stated there was only 20 mls of urine in the bag when there was actually 300 mls.

• Brand Name: SENSICA
• Type of Device: SENSICA MONITOR
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 9239752
• MDR Text Key: 178352838
• Report Number: 1018233-2019-06810
• 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
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• 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
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1