BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23233671 · Received October 7, 2025

    Report

    Report Number
    2016493-2025-120254
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 12, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE THAT DEVICE HAD FREE FLOW AFTER PAUSE COMMAND WAS NOT DETERMINED BECAUSE NO PRODUCT OR DEVICE LOGS WERE RETURNED. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Description of Event or Problem · 0

    RECEIVED A COPY OF THE CUSTOMER'S MAUDE DATABASE REPORT FROM FDA WHICH STATES"AS PART OF THEIR WORKFLOW, THE ANESTHESIOLOGISTS SET UP, PROGRAMMED THE INFUSION, AND PAUSED IT PRIOR TO ATTACHING THE INTRA VENOUS LINE TO THE PATIENT. THEY REPORTED THAT WHEN THEY PRESSED THE PAUSE BUTTON, THE DRUG CONTINUED TO DRIP (FREE FLOW)."NO PATIENTS WERE AFFECTED. FINDINGS RECENT LITERATURE AND AN FDA RECALL HIGHLIGHT CONCERNS REGARDING FREE FLOW EVENTS IN BD ALARIS¿ INFUSION PUMPS. AN ARTICLE FROM THE BRITISH JOURNAL OF ANESTHESIA (2025) DESCRIBES A NEAR MISS INVOLVING UNINTENDED FREE FLOW OF PROPOFOL DUE TO A MALFUNCTION WHILE THE PUMP WAS PAUSED, EMPHASIZING THE RISK OF PASSIVE FLOW WHEN THE TUBING IS NOT ADEQUATELY COMPRESSED. A 2006 STUDY IN ANESTHESIOLOGY REPORTS SIMILAR ISSUES WITH THE ALARIS 8100 PUMP, WHERE INCORRECT LOADING OF THE TUBING LED TO A FREE FLOW EVENT BECAUSE THE PUMP DOOR CLOSED IMPROPERLY, PREVENTING THE FLOW-STOP MECHANISM FROM FUNCTIONING. ADDITIONALLY, BD ISSUED A RECALL IN (B)(6) 2025 FOR ALARIS AND BD ALARIS PUMP MODULES SERVICED WITH OUTDATED BEZEL KITS, WHICH COULD DEGRADE OVER TIME AND LEAD TO SERIOUS RISKS LIKE FREE FLOW. DETAILED LOG REVIEW IN OUR CASE SHOWED CORRECT PROGRAMMING BY THE END USER, WITH THE PAUSE COMMAND ACKNOWLEDGED AND EXECUTED; HOWEVER, THE SYSTEM FAILED TO FUNCTION AS EXPECTED, LEADING TO A DRUG FREE FLOW. COLLECTIVELY, THESE FINDINGS UNDERSCORE THE CRITICAL NEED FOR PROPER PUMP MAINTENANCE, CORRECT INTRA VENOUS SET LOADING, AND ENHANCED DESIGN FEATURES TO PREVENT SUCH INCIDENTS.". THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439304 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Male 8015.