BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23366946 · Received October 23, 2025

    Report

    Report Number
    2016493-2025-125639
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 14, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403516023
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 REPORT THAT THE DEVICE HAD NETWORK COMMUNICATION ISSUES WAS CONFIRMED AND REPLICATED DURING THE INVESTIGATION. THE ISSUE WAS DETERMINED TO BE CAUSED BY A DEFECTIVE WIRELESS COMMUNICATION BOARD. THE SUSPECT DEVICE WAS TESTED IN ITS RECEIVED CONDITION BY CONNECTING IT TO AC POWER AND REVIEWING ITS NETWORK SETTINGS. INITIALLY, THE WIRELESS STATUS SHOWED ¿DISABLED,¿ AND ERROR CODE 600.6825 APPEARED, INDICATING A FAILED WIRELESS CONNECTION. AFTER SUCCESSFULLY INSTALLING THE DCHU LAB NETWORK CONFIGURATION PACKAGE, THE DEVICE STILL FAILED TO CONNECT, DISPLAYING ERROR CODE 600.6825. SUBSEQUENTLY, A DCHU LAB WIRELESS NETWORK CARD WAS TEMPORARILY INSTALLED INTO THE DEVICE FOR TESTING PURPOSES ONLY. UPON REBOOT, THE NETWORK STATUS CHANGED TO ¿ASSOCIATED,¿ AND THE DEVICE REMAINED CONNECTED WITHOUT ISSUES DURING EXTENDED MONITORING. THE DATE OF THE EVENT NOTED IN THE COMPLAINT WAS SEPTEMBER 10, 2025; HOWEVER, THE TIME WAS NOT PROVIDED. NO ACTIVITY WAS RECORDED ON THE EVENT DATE PROVIDED BY THE CUSTOMER. ADDITIONALLY, THE SAME ERROR CODE REPORTED AND SOME SIMILAR ERROR CODES (600.6840.5 - CIB CONNECTION FAILURE, 600.6870.5 - CIB COMMUNICATION FAILURE, 600.6830.5 - CIB CONFIGURATION FAILED) WERE REGISTERED A TOTAL OF TWO HUNDRED NINETY-ONE (291) TIMES BETWEEN APRIL 19, 2024, AND SEPTEMBER 8, 2025. THE EVENT LOGS INDICATE THAT THE LAST POWER-ON DURING WHICH AN INFUSION OCCURRED WAS ON (B)(6) 2025, AT 11:05 AM. TWO PUMP MODULES (S/N: (B)(6) WERE ADDED, WITH PUMP MODULE S/N: (B)(6) ASSIGNED TO CHANNEL A. A "NEW PATIENT" WAS NOT SELECTED, AND THE PROFILE USED WAS ¿ADULT STEPDOWN¿. AT 11:05 AM, PUMP MODULE (S/N: (B)(6) ON CHANNEL A WAS SELECTED AND A GUARDRAILS IV FLUIDS INFUSION WAS PROGRAMMED WITH THE FOLLOWING PARAMETERS: DRUGID = 1 IVF_PLAIN, RATE = 100 ML/H, VTBI = 999 ML FOR AN EXPECTED DURATION OF 10 HOURS. THE INFUSION WAS STARTED. PRIMARY VOLUME INFUSED (PVI) = 0 ML. AT 11:07 AM, A CIB MALFUNCTION WAS DISPLAYED (600.6820.5). FROM 11:07 AM TO 11:08 AM, AN OCCLUDED PATIENT SIDE ALARM WAS DISPLAYED. PVI = 2.794 ML. THE USER CONFIRMED THE ALARM, PRESSED THE SILENCE KEY, THEN THE CHANNEL OFF KEY. THE SYSTEM WAS POWERED OFF. NO OTHER INFUSION WAS PERFORMED. ACCORDING TO THE ALARIS SYSTEM USER MANUAL V12.3.1 IF THE STATUS APPEARS AS ¿DISABLED¿ OR ¿INVALID¿ AND THE WIRELESS CONNECTION SOFT KEY IS INACTIVE (GRAYED OUT) IT COULD BE FOR ONE OF THE FOLLOWING REASONS: SYSTEM MAINTENANCE WAS USED TO DISABLE THE WIRELESS CONNECTION. THE CF CARD FLASHING PROCESS WAS DONE WITHOUT THE PROGRAMMING OF THE PROPER APPCONFIG FILE (V9.12 OR LATER). A VALID NETWORK CONFIGURATION HAS NOT BEEN TRANSFERRED. THERE WAS NO PATIENT INVOLVEMENT. NOTES TO REPAIR CENTER: PLEASE REPLACE NETWORK CARD DUE TO INVESTIGATION FINDINGS. DEVICE OPENED FOR INVESTIGATION. PLEASE RE-TORQUE ALL SCREWS. REPAIR CENTER SHOULD FOLLOW THEIR NORMAL PROCESSING OF THE DEVICE, LOOKING ANY INCIDENTAL ISSUES PRIOR TO RETURNING IT TO THE CUSTOMER. DCHU WILL NOT COVER THE COSTS ASSOCIATED WITH ANY INCIDENTAL FINDINGS OR PHYSICALLY ABUSED COMPONENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD NETWORK CARD FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835233 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403516023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown