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

Catalog Number SCCS1001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

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 urine output was inaccurate.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was isolated to be use related.The load cell was damaged and the patient ring was overturned by the user.The load cell was replaced.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: " caution: when connecting the single patient use, sensica uo ring to the system stand, use a firm, clockwise twisting motion.Do not apply excessive force or torque to the ring or the system's interface when connecting the device to avoid damaging components." 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 urine output was inaccurate.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA MONITOR
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 9279079
• MDR Text Key: 179269653
• Report Number: 1018233-2019-07032
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1