MAUDE Adverse Event Report: ADAPTEC MEDICAL DEVICES LLC 3014271001 SENSICA

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 sensica device was not accurately recording volume.The complainant noted the device was 50-100 cc off of the accurate reading every hour.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue could not be determined due to the inability to reproduce the issue.The tech could not duplicate the reported issue during testing.Unit was functionally tested and no issues were sighted.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 monitor display shows how full the bag is, updating continuously along with the current hour uo measurement." 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 the sensica device was not accurately recording volume.The complainant noted the device was 50-100cc off of the accurate reading every hour.

• Brand Name: SENSICA
• Type of Device: SENSICA
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 9538907
• MDR Text Key: 178145872
• Report Number: 1018233-2020-00002
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• 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: 01/30/2020
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1