BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 24219686 · Received January 30, 2026

    Report

    Report Number
    2016493-2026-03143
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    October 14, 2025
    Report Date
    January 27, 2026
    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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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. ROOT CAUSE: THE REPORTED ISSUE THAT A SYRINGE MODULE WAS FOUND STOPPED AFTER A BOLUS WAS CONFIRMED THROUGH A LOG REVIEW, THE ROOT CAUSE IS ATTRIBUTED TO A CUSTOMER PROGRAMMING ERROR. LOG REVIEW IDENTIFIED THE CUSTOMER SELECTED THE OPTION ¿NO¿ TO A GUARDRAILS MESSAGE TO PROCEED WITH THE INFUSION. GUARDRAILS MESSAGE APPEARED FOR A DOSE OF 0.02 MG/KG/H PROGRAMMED FOR THE CONTINUOUS INFUSION THAT IS BELOW THE MINIMUM LIMIT OF 0.03 MG/KG/H. THE ¿NO¿ SELECTION PREVENTED THE CONTINUOUS INFUSION FROM PROCEEDING, ENSURING THAT ONCE THE PROGRAMMED BOLUS WAS COMPLETED, THE SYRINGE HAD NO FURTHER SCHEDULED ADMINISTRATION. INVESTIGATION SUMMARY: THE REPORTED COMPLAINT OF A SYRINGE MODULE WAS FOUND STOPPED WAS CONFIRMED THROUGH LOG REVIEW. NO DEVICES WERE RETURNED FOR THIS INVESTIGATION, HOWEVER, THE FACILITY PROVIDED LOGS TO INVESTIGATE THE REPORTED ISSUE. PCU MODULE EVENT LOG SHOWED ON 14 OCTOBER 2025, AT 2:58 PM AN IV REMOTE INFUSION WAS RECEIVED, THE DRUG WAS RECORDED AS ¿VECURONDRIP¿ (DRUG ID=488, SUSPECTED TO BE VECURONIUM DRUG). THE SELECTED SYRINGE WAS RECORDED AS A BD 20 ML SYRINGE AND THE INFUSION WAS PROGRAMMED AS CONTINUOUS WITH DOSE OF 0.02 MG/KG/H, RATE OF 0.18 ML/H AND VTBI OF 2.7435 ML. BEFORE STARTING THE INFUSION, A SOFT GUARDRAILS MESSAGE APPEARED, INDICATING THE DOSE WAS BELOW THE MINIMUM OF 0.03 MG/KG/H. THE USER PRESSED "YES" TO CONTINUE, BOLUS INFUSION WAS COMPLETED AS EXPECTED, RIGHT AFTER THE PROGRAMMED CONTINUOUS INFUSION STARTED. THE SAME PROGRAMMED BEHAVIOR WAS RECORDED AT 7:27 PM, BUT THE USER PRESSED "NO" TO CONTINUE. THE BOLUS WAS COMPLETED AS EXPECTED, RIGHT AFTER THE INFUSION REMAINED STOPPED. AT 9:06 PM THE USER PROGRAMMED THE SAME INFUSION AND PRESSED YES TO SOFT GUARDRAILS MESSAGE, AT 9:11 PM USER MADE AN ATTEMPT TO PROGRAM THE SAME BOLUS PARAMETERS, HOWEVER AT 9:40 PM PRESSED KEY CHANNEL OFF AND THE SYRINGE MODULE WAS TURNED OFF. THERE IS NO RECORD OF FURTHER INFUSIONS DURING THE REPORTED EVENT DAY. PER ALARIS SYSTEM WITH GUARDRAILS USER MANUAL V12.3.2 THE SYSTEM IS NOT INTENDED TO REPLACE SUPERVISION BY MEDICAL PERSONNEL. THE USER MUST BECOME THOROUGHLY FAMILIAR WITH THE SYSTEM FEATURES, OPERATION AND ACCESSORIES PRIOR TO USE. WHEN PROGRAMMING A CONTINUOUS INFUSION, IF THE PROGRAMMED CONTINUOUS DOSE INFUSION IS OUTSIDE THE SOFT LIMIT FOR THAT CARE AREA, AN AUDIO ALERT SOUNDS AND A VISUAL PROMPT APPEARS BEFORE PROGRAMMING CAN CONTINUE. IF YES SOFT KEY IS PRESSED, PROGRAMMING CONTINUES; IF NO SOFT KEY IS PRESSED, INFUSION NEEDS TO BE REPROGRAMMED. THE USER MANUAL ALSO STATES THAT ALL INFUSION PARAMETERS NEED TO BE REVIEWED AND CONFIRMED BY THE CLINICIAN BEFORE PRESSING START. 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 THAT THE SYRINGE MODULE STOPPED INFUSING PREMATURELY FOLLOWING A BOLUS INFUSION OF VECURONIUM. THERE WAS NO PATIENT INVOLVEMENT. A BOLUS DOSE OF VECURONIUM WAS ADMINISTERED AT 1928, HOWEVER IT THE SYRINGE MODULE TURNED OFF RATHER THAN TRANSITIONING BACK TO THE EXPECTED CONTINUOUS INFUSION. NO HARM OR IMPACT TO PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285166 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403516023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown