BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23263488 · Received October 10, 2025

    Report

    Report Number
    2016493-2025-121415
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 13, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403516023
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. THE REPORTED ISSUE OF SYSTEM ERROR CODE 133.6090 WAS CONFIRMED THROUGH REVIEW OF THE LOGS AND REPLICATED DURING DEVICE TESTING. A REVIEW OF THE SUSPECT PCU ERROR LOG SHOWED EIGHT (8) INSTANCES OF THE REPORTED ERROR CODE 133.6090 (MAIN_SPEAKER_FAILURE). THE FIRST INSTANCE WAS OBSERVED ON 14SEP2025 AT 4:30 PM AND THE LAST INSTANCE WAS OBSERVED ON 16SEP2025 AT 9:11 AM. THE SYSTEM WAS POWERED ON 14SEP2025 AT 4:30 PM, WHEN THE FIRST INSTANCE OF THE ERROR OCCURRED, THE SYSTEM WAS THEN POWERED OFF. THIS WAS REPEATED FOR EACH OF THE RECORDED INSTANCES OF ERROR 133.6090 AND NO OTHER ACTIVITY WAS RECORDED FOR THE DEVICE AFTER 16SEP2025 AT 9:11 AM. THE CONNECTION BETWEEN THE SIO BOARD (MAIN SPEAKER BOARD) AND THE LOGIC BOARD WAS INSPECTED TO OBSERVE IF THERE WAS A CONNECTION ISSUE. NO ANOMALIES WERE OBSERVED. THE SIO BOARD WAS DISCONNECTED AND CONNECTED AGAIN AND THE DEVICE WAS POWERED ON. THE DEVICE POWERED ON WITHOUT ANY ISSUES OR ALARMS APPEARING. THIS PROCESS WAS REPEATED A TOTAL OF TEN (10) TIMES AND THE SYSTEM POWERED ON SUCCESSFULLY AFTER EVERY TRIAL. A DCHU TEST PUMP MODULE WAS ATTACHED TO THE RECEIVED PCU AND A TWO-HOUR INFUSION WAS PROGRAMMED AND STARTED. NO MALFUNCTIONS OR ALARMS WERE OBSERVED DURING OR AFTER THE INFUSION WAS COMPLETED. THE SPEAKER WAS ALSO TESTED THROUGH THE ¿AUDIO VOLUME ADJUST¿ SCREEN ON THE PCU MAIN MENU AND THE SPEAKER SUCCESSFULLY ALARMED WHEN THE TEST KEY WAS PRESSED. THE SUSPECT PCU UNDERWENT MAINTENANCE TASKS THROUGH THE ALARIS SYSTEM MAINTENANCE SOFTWARE (V12.3) TO TEST THE PCU¿S FUNCTIONALITY. TEST RESULTS SHOW THE DEVICE PASSING ALL PREVENTATIVE MAINTENANCE TESTS AS REQUIRED. THE SIO BOARD WAS INSPECTED FOR ANY ANOMALIES. IT WAS NOTED THAT THE SPEAKER WAS MISALIGNED AND SLIGHTLY DETACHED FROM THE BACK OF THE BOARD. THIS IS CONSIDERED AN INCIDENTAL FINDING AS IT WAS NOT A CONTRIBUTING FACTOR TO THE REPORTED INCIDENT. THE SYSTEM ERROR TIPSHEET STATES TO DO THE FOLLOWING WHEN ENCOUNTERING A SYSTEM ERROR ON THE PC UNIT: ¿OBTAIN A NEW PCU. DO NOT POWER DOWN UNTIL A NEW PCU IS AVAILABLE. OPERATION WILL CONTINUE ON ALL CHANNELS DURING THIS TIME. PROGRAMMED SETTINGS ON THE MODULE ARE NOT RESTORABLE, ANY CURRENT RATE, DOSE AND VTBI SETTINGS SHOULD BE NOTED AND RECORDED PRIOR TO POWERING DOWN THE PCU. TAG THE AFFECTED PCU, DESCRIBE THE ERROR AND RETURN IT TO YOUR FACILITY¿S CLINICAL ENGINEERING OR BIOMED DEPARTMENT.¿ THE DEVICE WAS REPORTEDLY IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). NOTE TO REPAIR CENTER: MODEL 8015 PCU SN 16318659 (SUSPECT) DEVICE WAS DISASSEMBLED FOR THIS INVESTIGATION, PLEASE ENSURE PROPER ASSEMBLY, TORQUING OF SCREWS, AND APPROPRIATE TESTING IS PERFORMED. PLEASE REPLACE THE SIO BOARD AS A PREVENTATIVE MEASURE. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING FOR ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DCHU WILL NOT BE PICKING UP THE COST OF THE INCIDENTAL REPAIRS. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD SYSTEM ERROR CODE= 133.6090. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD SYSTEM ERROR CODE= 133.6090. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112356 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403516023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown