BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICA UO MONITOR ICU

    MDR report key: 10126636 · Received June 7, 2020

    Report

    Report Number
    1018233-2020-03668
    Event Type
    Malfunction
    Date Received
    June 7, 2020
    Report Date
    September 23, 2020
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    EXS
    UDI-DI
    00854003008002
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED, HOWEVER THE CAUSE WAS UNKNOWN. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO A DEFECTIVE LOAD CELL. THE BIOMED STATED THAT THEY REPLACED THE LOAD CELL AND DISCARDED IT. AS A PART OF THE FIELD ACTION, THE FOLLOWING COMPONENTS WERE REPLACED/ADDED AS PER THE LATEST REVISION OF THE BILL OF MATERIAL FOR SENSICA ICU, PRODUCT CODE SCCS1001.005-0004 REV H BASE PCBA, 005-0102 REV C SENSICA ICU BASE PCBA FIRMWARE, 005-0100 REV D SENSICA ICU APPLICATION SOFTWARE, 005-0220 REV A WINDOWS ENTERPRISE OS, 005-2083 REV A POWER SUPPLY LABEL. PRODUCT LABEL 005-0094, USB CONNECTION LABEL, WAS REPLACED WITH THE LATEST REVISION OF THE LABEL (REV C) PER THE LATEST BILL OF MATERIAL FOR SENSICA ICU, PRODUCT CODE SCCS1001. REPLACED PCBA 005-0004 REV H WITH THE FIRMWARE 1.2.14 - SERIAL NUMBER (B)(6). SERVICING OF THE UNIT WAS PERFORMED AS PER THE TEST PROCEDURE. THE DEVICE WAS FUNCTIONING PROPERLY AND WAS READY FOR USE. THE PRODUCT WOULD NOT MEET THE SPECIFICATIONS, AND WAS INFLUENCED BY THE REPORTED FAILURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A LOAD CELL ISSUE IN THE SENSICA DEVICE. PER FOLLOW UP ON 27MAY2020, BIOMED PEOPLE STATED THAT THEY REPLACED THE LOAD CELL AND DISCARDED IT. THE DEVICE CURRENTLY IN SERVICE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOAD CELL ISSUE IN THE SENSICA DEVICE. PER FOLLOW UP ON 27MAY2020, BIOMED STATED IT REPLACED THE LOAD CELL AND DISCARDED IT. THE DEVICE CURRENTLY IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590407 SENSICA UO MONITOR ICU SENSICA EXS ADAPTEC MEDICAL DEVICES LLC 3014271001 SCCS-1001 NA 00854003008002

    Patients

    Seq Age Sex Outcome Treatment
    1