BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21525124 · Received March 5, 2025

    Report

    Report Number
    2016493-2025-64248
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 10, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    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 DEVICE DISPLAYED AN ERROR CODE 242.4030 WAS CONFIRMED DURING THE REVIEW OF THE ERROR LOG AND WAS REPLICATED DURING TESTING. ¿ THE OPTOCOUPLER OF THE AIL SENSOR (OP1) IT WAS OBSERVED TO BE BROKEN. ¿ THE DAMAGED AIL SENSOR WAS TEMPORARILY REPLACED FOR TESTING PURPOSES ONLY WITH A KNOWN GOOD LAB AIL ASSEMBLY. ASM PREVENTIVE MAINTENANCE TESTING WAS PERFORMED AND FOUND THE DEVICE TO BE IN SPECIFICATION. ¿ A PRIMARY INFUSION WAS PROGRAMMED AND WAS LEFT INFUSING FOR TWELVE (12) HOUR. THE ERROR 242.4030 WAS NOT DISPLAYED AGAIN. ¿ A REVIEW OF PUMP MODULE ERROR LOG SHOWED THAT FROM JANUARY 22 TO FEBRUARY 06 IT WAS RECORDED SIX (6) TIMES ERROR CODE 242.4030 (MOTOR_STALL_FAILURE); THIS ERROR INDICATES A POSSIBLE PROBLEM WITH MOTOR SYSTEM. ¿ THE LOG ANALYSIS BEGINS ON FEBRUARY 06, 2025, AT 9:53 AM, WHEN THE LAST INFUSION WAS RECORDED WITH A RATE OF 999ML/H AND A VTBI (VOLUME TO BE INFUSION) OF 50ML. THE PROFILE IN USE WAS IDENTIFIED AS ¿010325 WMC 12_1_3¿. ¿ THE INFUSION STARTED AT 9:53 AM, IMMEDIATELY, THE INFUSION WAS STOPPED BY A CHANNEL MALFUNCTION: ERROR CODE 242.4030 (MOTOR_STALL_FAILURE), THEN, THE PUMP MODULE WAS POWERED OFF. ¿ BD ALARIS¿ SYSTEM CHANNEL ERROR TIP SHEET STATES TO SILENCE THE ALARM AND CONTINUE UNAFFECTED CHANNEL OPERATION, PRESS THE CONFIRM SOFT KEY. OBTAIN A NEW MODULE. OPERATION OF THE AFFECTED CHANNEL STOPS. IT MAY BE NECESSARY TO UTILIZE THE RESTORE FUNCTION ON UNAFFECTED CHANNELS THAT MAY HAVE BEEN ATTACHED AND REATTACHED TO THE BD ALARIS¿ PC UNIT DURING THE ALARM STATE. RETURN THE AFFECTED MODULE TO YOUR FACILITY¿S BIOMED DEPARTMENT. ¿ THE BD ALARISTM SYSTEM WITH GUARDRAILSTM SUITE MX USER MANUAL V12.1 STATES THAT DO NOT USE A DEVICE THAT APPEARS TO BE DAMAGED. SEND THE DEVICE TO BIOMEDICAL ENGINEERING FOR REPAIR. ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). NOTE TO REPAIR CENTER DEVICES WERE OPENED FOR INVESTIGATION, PLEASE RE-TORQUE ALL SCREWS. 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 COVER THE COSTS ASSOCIATED WITH ANY INCIDENTAL FINDINGS OR PHYSICALLY ABUSED COMPONENT 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 DISPLAYED AN ERROR CODE 242.4030. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 242.4030. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447956 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown