BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23422320 · Received October 30, 2025

    Report

    Report Number
    2016493-2025-127868
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    September 26, 2025
    Report Date
    December 11, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION: DATE OF BIRTH. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL? RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER? IMDRF ANNEX A, G, B, C AND D CODES AND MANUFACTURER NARRATIVE. 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. INVESTIGATION SUMMARY: THE REPORTED EVENT OF" INFUSED QUICKER THAN EXPECTED " COULD NOT BE CONFIRMED THROUGH LABORATORY TESTING OR LOG REVIEW. THE PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATION. DURING THE INTERNAL AND EXTERNAL INSPECTION OF THE SUSPECT PUMP MODULE, THERE WERE NO ISSUES OR ANOMALIES IDENTIFIED DURING THE INSPECTION OF THE DEVICE. ALL PARTS INSPECTED WERE MANUFACTURED BY BD. FIVE TRIALS WERE CONDUCTED AT INFUSION RATES OF 0.1ML/H, 1ML/H, WML/H, 100ML/H, AND 999ML/H IN ACCORDANCE WITH THE TIMED RATE ACCURACY PRODUCT ANALYSIS PROCEDURE (1503-001-006 (03), DIR#: 10000360036). NO INSTANCES OF UNREGULATED FLOW WERE OBSERVED. RATE ACCURACY TESTING WAS PERFORMED ON THE SUSPECT PUMP MODULE. THE DEVICE WAS FOUND TO BE DELIVERING FLUID WITHIN SPECIFICATION. SPRING FUNCTIONAL TESTS OBSERVED NO ISSUES, AND ALL TESTS PASSED, INDICATING THE OCCLUDERS AND SPRINGS WERE FUNCTIONING AS INTENDED. A REVIEW OF THE LOGS WAS CONDUCTED FOR THE DATE OF THE EVENT REPORTED BY THE FACILITY (26SEP2025). THE PCU S/N: (B)(6) WAS POWERED ON AT 12:37 AM ALONG WITH THE SUSPECTED PUMP MODULE S/N: (B)(6) ON CHANNEL B, WITH A PRIMARY VOLUME INFUSED (PVI) OF 140.80 ML AND A SECONDARY VOLUME INFUSED (SVI) OF 400 ML FROM PREVIOUS INFUSIONS. AT 12:44 AM, THE PCU RECEIVED A REMOTE IV, PROGRAMMED WITH DRUG ID: 230 (SUSPECTED TO BE THE DRUG MENTIONED BY THE FACILITY, AVYCAZ), WITH A RATE OF 50 ML/H AND A VTBI OF 100 ML. THE INFUSION THEN STARTED, AND AT 12:51 AM, AN AIRIN-LINE ALARM OCCURRED. THE INFUSION RESTARTED AT 12:55 AM, AND AGAIN AN AIR-IN-LINE ALARM WAS TRIGGERED. THE INFUSION STOPPED WITH A PVI OF 147.14 ML. AT 1:12 AM, THE CHANNEL OFF KEY WAS PRESSED ON THE PUMP MODULE, AND THE ENTIRE EQUIPMENT WAS POWERED OFF. THE BD ALARIS¿ SYSTEM WITH GUARDRAILS¿ SUITE MX V12.3.2 USER MANUAL STATES THAT TO PREVENT A POTENTIAL UNCONTROLLED FLOW (FREE-FLOW) CONDITION, ENSURE THAT NO EXTRANEOUS OBJECT (FOR EXAMPLE, BEDDING, TUBING, GLOVE) IS ENCLOSED OR CAUGHT IN THE PUMP MODULE DOOR. TO PREVENT A POTENTIAL UNCONTROLLED FLOW (FREE-FLOW CONDITION), DO NOT USE AN INFUSION MODULE IF IT IS DAMAGED IN ANY WAY OR DOES NOT APPEAR TO BE FUNCTIONING AS EXPECTED. UNCONTROLLED FLOW (FREE-FLOW) CAN RESULT IN PATIENT HARM. THE PUMPING MECHANISM WAS DISASSEMBLED DURING THE INTERNAL INSPECTION. THE MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO DCHU, REPAIR CENTER, OR THE FACILITY. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED EVENT OF ¿INFUSED QUICKER THAN EXPECTED' COULD NOT BE DETERMINED THROUGH LABORATORY TESTING OR LOG REVIEW. THE PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATION. 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.

    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 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

    IT WAS REPORTED A ROUTINE ORDER OF AVYCAZ INFUSED FASTER THAN EXPECTED. THE INTENDED RATE OF INFUSION WAS 50ML/HR WITH A TOTAL VOLUME TO BE INFUSED OF 100ML. PER REPORT, 100MLS INFUSED IN FIFTEEN (15) MINUTES. THERE WERE NO OTHER INFUSIONS RUNNING AT THE TIME OF THE EVENT. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED A ROUTINE ORDER OF AVYCAZ INFUSED FASTER THAN EXPECTED. THE INTENDED RATE OF INFUSION WAS 50ML/HR WITH A TOTAL VOLUME TO BE INFUSED OF 100ML. PER REPORT, 100MLS INFUSED IN FIFTEEN (15) MINUTES. THERE WERE NO OTHER INFUSIONS RUNNING AT THE TIME OF THE EVENT. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297944 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male 8015.| 8100.