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

Model Number SCCS-1001

Device Problems Computer Operating System Problem (2898); Appropriate Term/Code Not Available (3191)

Patient Problems No Patient Involvement (2645); 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 had a load cell issue.

Event Description

It was reported that the sensica device had a load cell issue.Per follow up on 28may2020, engineer (b)(6) stated the sensica unit is being returned to bd for repairs.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.The device was working properly.The device went through field action, the following components were replaced/added per the latest revision of the bill of material for sensica icu,rev h base pcba, rev c sensica icu base pcba firmware, rev d sensica icu application software, rev a windows enterprise os, rev a power supply label.Product label, usb connection label, was replaced with the latest revision of the label (rev c) per the latest bill of material for sensica icu.Replaced pcba, rev h with firmware.Servicing of the unit was performed per test procedure.The device functioned properly and ready for use.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 ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.Indications: the sensica uo system is an automated urine meter system for continuous monitoring of urine output (uo) and core body/bladder temperature (bt).To attach the ring to the sensica uo system stand, turn the ring upside down and use a clockwise motion to twist and "lock" the ring onto the ring interface.Do not apply excessive force or torque to the ring or the system's ring interface when connecting the device to avoid damaging components.Do not turn the ring counterclockwise when attaching it." 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.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 10095855
• MDR Text Key: 193112132
• Report Number: 1018233-2020-03473
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00854003008002
• UDI-Public: (01)00854003008002
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCCS-1001
• Device Catalogue Number: SCCS1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1